MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-01 for TOROSA SALINE TESTICULAR LARGE 5206502400 manufactured by Coloplast A/s.
[39700172]
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
[39700173]
Testicular was noted leaking when 80% of the implant was filled, as per protocol. Bilateral restoration was not possible, surgeon placed one implant, closed the other site. Patient will undergo a secondary procedure to place other implant.
Patient Sequence No: 1, Text Type: D, B5
[44577936]
This follow-up mdr was created to document the evaluation of the returned device as follows: one torosa saline testicular implant was received for evaluation. Examination and testing of the returned device identified a point of leakage on the shell of the device, as reported. Microscopic examination of the site revealed a small hole with a central groove, indicating it was caused by contact with a small sharp instrument such as a needle. Signs of the separation are more apparent on the inside of the shell indicating that the insertion point of the needle was on the inside of the implant. It was also noted that the location of the separation is consistent with where the end of the needle would be during filling. Based on these observations, it was concluded that the inside of the device came into contact with the needle used for filling the device during filling which caused the separation and subsequent leakage. This instrument damage to the device during preparation is associated with the root cause of the failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2016-00018 |
| MDR Report Key | 5470505 |
| Date Received | 2016-03-01 |
| Date of Report | 2016-05-03 |
| Date of Event | 2016-02-08 |
| Date Mfgr Received | 2016-02-08 |
| Date Added to Maude | 2016-03-01 |
| 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 | SALINE FILLED TESTICULAR PROSTHESIS, |
| Product Code | FAF |
| Date Received | 2016-03-01 |
| Returned To Mfg | 2016-03-24 |
| Model Number | 5206502400 |
| Catalog Number | 5206502400 |
| 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, DA 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-01 |