Additional Manufacturer Narrative · 1
BASED ON A REVIEW OF THE INFO, THE INCIDENT IS NOT A REPORTABLE EVENT PER 21 CFR, SECTION 803. THERE WAS NO DEATH. THERE WAS NO SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. BALLOON RUPTURES/TEARS ARE COMMON AMONG ALL ENTERAL DEVICES WITH A BALLOON. PLEASE BE ADVISED THAT IN BALLOON GASTROSTOMY FEEDING TUBES, ALL BALLOONS WILL EVENTUALLY TEAR, BREAK, OR FAIL WHILE IN SITU, THUS RENDERING THE DEVICE NON-FUNCTIONAL. THIS IS TRUE WHETHER THE DEVICE IS OURS OR ANY OF OUR COMPETITORS. DEPENDING ON MANY PT-RELATED OR CAREGIVER-RELATED FACTORS, SUCH AS STOMACH PH, TYPE OF MEDICATIONS, BUTTON CARE, BUTTON PLACEMENT, OR MECHANICAL DURESS (SUCH AS HEAVY COUGHING) WHILE IN SITU, THE BALLOON MAY FUNCTION ANYWHERE FROM DAYS TO SEVERAL MONTHS IN THE PT. ADDITIONALLY, THE USER STATES THAT THE DEVICE WAS RETURNED TO THE MFR (APPLIED MEDICAL TECHNOLOGY, INC) WHICH IS INCORRECT. APPLIED MEDICAL TECHNOLOGY HAS NOT RECEIVED THE DEVICE REFERENCED IN THIS REPORT. THE DEVICE INFO GIVEN IN THE REPORT, STATES THAT, THAT FAILED DEVICE IS PART #: M1-5-1408 AND FROM LOT #: 12100117. A REVIEW OF OUR COMPLAINT DATABASE DID NOT FIND A RETURNED OR REPORTED COMPLAINT WITH THIS DEVICE INFO. THEREFORE, AN ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. IN ADDITION, A DHR REVIEW SHOWED NO ANOMALIES FOR LOT: 12100117. IT SHOULD ALSO BE NOTED THAT THE AMT REPLACEMENT DEVICE IS A DISPOSABLE DEVICE, REQUIRING PERIODIC REPLACEMENT. AMT WILL PROVIDE ADD'L INFO TO THE FDA WHEN/IF THE DEVICE IS ABLE TO BE RETRIEVED AND ANALYSIS OF THE DEVICE CHANGES THE CONCLUSION OF THIS REPORT.