MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-02-22 for TOROSA 5206502400 6206502400 manufactured by Coloplast A/s.
[21757686]
The device kept deflating. Pt has surgery to remove/replace device. Explant date unk.
Patient Sequence No: 1, Text Type: D, B5
[21889463]
On saline testicular device was received for eval. Examination and testing of the returned device revealed no separations in the shell, near the midline. Testing revealed these to both be sites of leakage. Microscopic examination of the separations revealed them to both have a central groove, indicating contact with sharp instrumentation such as a needle. Colopast concludes that the two separations in the shell near the midline were most likely a result of needle sticks, due to the central grooves noted. However, as the info provided did not indicate any leakage noted, coloplast was unable to determine when these needle sticks may have occurred. The product literature that accompanies this device addresses potential post operative complications such as this.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2012-00007 |
| MDR Report Key | 2708672 |
| Report Source | 06 |
| Date Received | 2012-02-22 |
| Date of Report | 2012-02-21 |
| Date of Event | 2011-11-11 |
| Date Mfgr Received | 2012-01-23 |
| Date Added to Maude | 2012-08-23 |
| 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, 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 PROSTHESIA, PRODUCT CODE: FAF |
| Product Code | FAF |
| Date Received | 2012-02-22 |
| Model Number | 5206502400 |
| Catalog Number | 6206502400 |
| Lot Number | 2894991 |
| 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 3050 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-02-22 |