MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-28 for SALINE-FILLED TESTICULAR PROSTHESIS 5206501000 manufactured by Coloplast Manufacturing Us Llc.
[1007521]
As reported to coloplast, a physician reported leakage of a testicular prosthesis, which reportedly ruptured spontaneously a few days after implant.
Patient Sequence No: 1, Text Type: D, B5
[8156342]
One testicular device was received for eval. Investigation results are pending. A follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2009-00001 |
| MDR Report Key | 1297574 |
| Report Source | 05 |
| Date Received | 2009-01-28 |
| Date of Report | 2008-12-29 |
| Date of Event | 2008-12-12 |
| Date Mfgr Received | 2008-12-29 |
| Date Added to Maude | 2009-02-06 |
| 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, MGR |
| Manufacturer Street | 1499 W 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 |
| 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 | 2009-01-28 |
| Model Number | 5206501000 |
| Catalog Number | 5206501000 |
| Lot Number | 5717984 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST MANUFACTURING US LLC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-28 |