MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-15 for TOROSA 5206501400 manufactured by Coloplast A/s.
[2109285]
Testicular placed uneventfully during procedure and appeared to be in good condition. On subsequent exams the prosthesis was riding high and hard & appeared to have deflated. Patient requested removal. Physician feels the implant is defective.
Patient Sequence No: 1, Text Type: D, B5
[2448900]
Testicular placed uneventfully during procedure and appeared to be in good position. On subsequent exams the prosthesis was riding high and hard & appeared to have deflated. Patient requested removal of the implant. Physician feels the implant is defective.
Patient Sequence No: 1, Text Type: D, B5
[9244688]
Evaluation pending. A follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[9557004]
One saline testicular device was received for evaluation. Examination and testing of the returned device revealed no functional abnormalities. Leakage testing was performed. No leakage was observed during the testing of the device. Microscopic examination revealed one puncture in the injection port of the device. There was no indication that the injection port had been punctured with a needle to be filled prior to implant as the device instructions for use (ifu) states.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2011-00003 |
| MDR Report Key | 2163999 |
| Report Source | 05 |
| Date Received | 2011-07-15 |
| Date of Report | 2011-06-16 |
| Date Mfgr Received | 2011-06-16 |
| Device Manufacturer Date | 2010-08-18 |
| Date Added to Maude | 2011-07-18 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIM CRABTREE-RA MANAGER |
| Manufacturer Street | 1601 W. RIVER ROAD N |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024922 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1601 W. RIVER ROAD N |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOROSA |
| Generic Name | SALINE FILLED TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2011-07-15 |
| Returned To Mfg | 2011-06-16 |
| Model Number | 5206501400 |
| Catalog Number | 5206501400 |
| Lot Number | 2506164 |
| Device Expiration Date | 2012-09-30 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM-1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-15 |