TOROSA SALINE TESTICULAR LARGE
Received Dec 19, 2019
Report 2125050-2019-01138 · MDR key 9497735
Device
Generic name
Saline Filled Testicular Prosthesis
Manufacturer
Coloplast A/sModel number
5206502400Catalog number
520650
Lot number
4729276
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
58 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP WAS CREATED TO DOCUMENT THE CONCLUSION OF THE INVESTIGATION. ONE TESTICULAR DEVICE WAS RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED DEVICE REVEALED A SEPARATION IN THE SHELL OF THE TESTICULAR NEAR THE MIDLINE. TESTING REVEALED THIS TO BE A SITE OF LEAKAGE. MICROSCOPIC EXAMINATION OF THE SEPARATION REVEALED IT TO HAVE A CENTRAL GROOVE, INDICATING CONTACT WITH SHARP INSTRUMENTATION SUCH AS A NEEDLE. THE INJECTION PORT WAS CONFIRMED TO CONTACT A NEEDLE STICK, INDICATING THE DEVICE HAD MOST LIKELY BEEN FILLED DURING THE IMPLANT PROCEDURE. BECAUSE THIS COMPONENT WAS RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, IT WAS CONCLUDED THAT THE OBSERVED INSTRUMENT SEPARATION IN THE TESTICULAR SHELL OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. CONFIRMATION OF A NEEDLE STICK WAS NOTED IN THE INJECTION PORT, INDICATING THE DEVICE MOST LIKELY WAS FILLED DURING THE IMPLANT PROCEDURE. BASED ON THE EVALUATION AND INFORMATION RECEIVED, IT WAS CONCLUDED THAT THE SEPARATION MAY HAVE OCCURRED INADVERTENTLY DURING THE IMPLANT PROCEDURE. THE INFORMATION RECEIVED DID NOT INDICATE HOW LONG THE DEVICE WAS IMPLANTED PRIOR TO NOTING THE REPORTED DEFLATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RECEIVED AT COLOPLAST; HOWEVER THE EVALUATION IS NOT YET COMPLETE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, MONTHS AFTER THE IMPLANT OF THE DEVICE, THE PATIENT NOTICED THE IMPLANT HAD DEFLATED (THE EVENT WAS OBSERVED IN SEPTEMBER 2019). ANOTHER TOROSA WAS IMPLANTED.