MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-09-21 for TOROSA SALINE TESTICULAR LARGE 5206502400 manufactured by Coloplast A/s.
[86983996]
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted
Patient Sequence No: 1, Text Type: N, H10
[86983997]
According to the available information, on examination of the implant, the surgeon noticed a mark on filling the implant. The prosthesis started to leak at this defective mark. Additional information received 08/31/2017: procedure not completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[113571493]
One torosa device was received for evaluation. Examination and testing of the returned component revealed a separation between the mid line and injection port on the shell of the device. Testing revealed this to be a site of leakage. Microscopic examination of the surface revealed a small separation with a central groove indicating the area was in contact with a small sharp instrument such as a needle. Because this component was released according to manufacturing and quality control procedures, quality concluded that the observed instrument damage on the testicular shell occurred subsequent to the device packaging being opened, most likely during the prepping/filling of the device for surgery. Management routinely reviews events such as this and monitors complaint levels. Additionally, events of this type are captured in the product risk documentation. Based on this information no further corrective action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2017-00433 |
| MDR Report Key | 6883814 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-09-21 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-08-02 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-09-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINE BUCKVOLD |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024982 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| 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 SALINE TESTICULAR LARGE |
| Generic Name | TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2017-09-21 |
| Returned To Mfg | 2017-08-31 |
| Model Number | 5206502400 |
| Catalog Number | 5206502400 |
| Lot Number | 5675338 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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. Other | 2017-09-21 |