MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-18 for TOROSA 5206502400 manufactured by Coloplast A/s.
[3666607]
As reported to coloplast but not verified, leakage was reported during filling. Patient was subsequently implanted on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
[11044746]
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2013-00075 |
| MDR Report Key | 3233982 |
| Report Source | 06 |
| Date Received | 2013-07-18 |
| Date of Report | 2013-06-18 |
| Date of Event | 2013-06-21 |
| Date Mfgr Received | 2013-06-21 |
| Date Added to Maude | 2013-07-18 |
| 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 | 2013-07-18 |
| Returned To Mfg | 2012-04-16 |
| Model Number | 5206502400 |
| Catalog Number | 5206502400 |
| Lot Number | 3557262 |
| Device Expiration Date | 2017-12-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2013-07-18 |