MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-04 for SALINE-FILLED TESTICULAR PROSTHESIS 450-1329-E manufactured by Coloplast Manufacturing Us, Llc.
[921312]
As reported to coloplast, the testicular implant became infected, with purulent material noted in the dependent portion of the prosthesis. Implant was removed and pt was discharged with antibiotics. Culture results were positive for staph aureus.
Patient Sequence No: 1, Text Type: D, B5
[8198537]
Coloplast was unsuccessful in securing the explanted prosthesis for eval, as the initial reporter stated the device would not be returned. However, because qa's examination may not conclusively confirm or disprove the report of infection, coloplast accepts the physician's observations of such as the reason for surgical intervention. A review of the lot history records indicates this lot passed sterility testing prior to being released. Based on this knowledge, it is concluded that the device was sterile prior to the device packaging being opened and that the infection originated from source(s) other than device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2008-00005 |
| MDR Report Key | 1153226 |
| Report Source | 05 |
| Date Received | 2008-09-04 |
| Date of Report | 2008-08-07 |
| Date of Event | 2008-07-11 |
| Date Mfgr Received | 2008-08-07 |
| Date Added to Maude | 2008-09-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBEKA STOLTMAN, RA MGR |
| Manufacturer Street | 1499 WEST RIVER RD N |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024997 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1525 WEST RIVER RD. NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SALINE-FILLED TESTICULAR PROSTHESIS |
| Generic Name | TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2008-09-04 |
| Model Number | 450-1329-E |
| Catalog Number | 450-1329-E |
| Lot Number | 5710062 |
| ID Number | 5207501000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1176677 |
| Manufacturer | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-04 |