For several years now, it has been mandatory that any medical professional who witnesses or is made aware of any patient injured by any medical device is required to report that injury to the FDA.  As Linda Smith noted, FDA has a system for reporting and investigating these reports to ascertain whether the equipment poses a risk to patient safety.  Instead of telling the patient to call, the medical professional needs to report it.  
A couple of weeks ago, someone mentioned that the FDA is going to add breast pumps to the items it oversees.  FYI...breast pumps have fallen under the scrutiny of the FDA for a very long time now.  Breast pumps cannot be legally marketed in the US unless the company has received permission to market the pump.  This is obtained through a 510K filing in which the company is required to submit all information regarding function, labeling, claims and instructions.  Manufacturers are also required to keep a complaint file for each patient who has submitted any complaint at all about the product.  Under the FDA regs, a complaint can even be when someone doesn't like the color of the pump or the length of the tubing!  It takes an average of 6-12 months for a manufacturer to receive permission to market a new medical device.
So, please...all you medical professionals....you are required to report each and every injury..even the ones from the equipment you are renting.  For more information about this, call MedWatch and ask about the Safe Medical Devices Act.  They may be willing to send you a copy for your own edification.  You can also order copies of the Medical Device Report for any injuries to patients from breast pumps of all kinds. Another source for these reports is ECRI in Pennsylvania.  ECRI takes in data from the FDA and several other sources and provides an all-inclusive report on injuries or deaths caused by any classification of medical equipment.  You can have them sort for a time frame also.  By and large, breast pumps aren't dangerous pieces of equipment for mothers to fear, but the reports will surprise you.  Happy Valentines Day.  Elena Taggart Medo, Chairman, White River Concepts (www.whiteriver.com)