MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-30 for TOROSA 5206302400 manufactured by Coloplast A/s.
[2935789]
Device eroded through the scrotum.
Patient Sequence No: 1, Text Type: D, B5
[10360991]
One testicular device was returned for evaluation. Examination of the returned component revealed no abnormalities that would have contributed to the report of erosion. Coloplast accepts the physician's observations of such as the reason for surgical intervention. The product literature that accompanies this device addresses the potential post operative complications such as this.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2012-00022 |
| MDR Report Key | 2822180 |
| Report Source | 06 |
| Date Received | 2012-04-30 |
| Date of Report | 2012-04-30 |
| Date of Event | 2012-04-03 |
| Date Mfgr Received | 2012-04-03 |
| Device Manufacturer Date | 2011-04-11 |
| Date Added to Maude | 2012-11-08 |
| 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 | 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 FILED TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2012-04-30 |
| Returned To Mfg | 2012-04-03 |
| Model Number | 5206302400 |
| Catalog Number | 5206302400 |
| Lot Number | 3000205 |
| Device Expiration Date | 2016-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM-1 HUMLEBAEK, DA 4138 4138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-30 |