SALINE-FILLED TESTICULAR PROSTHESIS
Received Dec 31, 2008
Report 2125050-2008-00012 · MDR key 1276470
Device
Generic name
Testicular Prosthesis
Manufacturer
Coloplast Manufacturing Us, LlcModel number
5207501000Catalog number
5207501000
Lot number
5712686-015
Product problems
- Filling Problem
- Device Damaged Prior to Use
- Out-Of-Box Failure
Patient
Not reported
- Surgical procedure, delayed
Narrative
Description of Event or Problem
AS REPORTED TO COLOPLAST, A PHYSICIAN REPORTED A PROSTHESIS WAS DAMAGED UPON RECEIPT, SO IT COULD NOT BE FILLED JUST PRIOR TO IMPLANT SURGERY, WHICH HAD TO BE POSTPONED.
Additional Manufacturer Narrative
ONE TESTICULAR DEVICE WAS RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE DEVICE REVEALED A SEPARATION ON THE SUTURE TAB. MICROSCOPIC EXAMINATION OF THE SEPARATION REVEALED A SMOOTH AND STRAIGHT EDGE INDICATING SHARP INSTRUMENTATION WAS INVOLVED. BECAUSE THESE COMPONENTS WERE RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT THE OBSERVED INSTRUMENT SEPARATION ON THE SUTURE TAB OCCURRED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. AS THE DEVICE WAS NEVER IMPLANTED. QA CONCLUDED THAT INSTRUMENT DAMAGE MOST LIKELY OCCURRED DURING THE DEVICE PREPPING PROCESS PRIOR TO IMPLANT.