MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-06-21 for TENOGLIDE TENDON PROTECTOR SHEET SINGLE 2IN X 2IN TG221 manufactured by Integra, Plainsboro.
[20791589]
The reported stated that the pt had surgery on (b)(6) 2011 for a left dorsal wrist mass. The procedures were dorsal wrist ganglionectomy, wrist joint capsulorrhaphy, and wrist joint synovectomy. On (b)(6) 2011, the pt complained of a large bump on the left hand at the incision site, with numbness of the knuckles, and inability to flex or extend, and heat at the site. Hematoma was diagnosed and aspiration was attempted but was not successful. On (b)(6) 2011, the pt complained of return of the ganglion cyst on her hand. The mass was on the tendon that was excised and where tenoglide was placed over the tendons. On (b)(6) 2011, revision surgery was performed. Integra has requested additional clinical info.
Patient Sequence No: 1, Text Type: D, B5
[20830038]
The device involved in the reported incident is not expected to be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2011-00019 |
| MDR Report Key | 2140951 |
| Report Source | 05,07 |
| Date Received | 2011-06-21 |
| Date of Report | 2011-06-21 |
| Date Mfgr Received | 2011-06-03 |
| Date Added to Maude | 2011-07-05 |
| 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 | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TENOGLIDE TENDON PROTECTOR SHEET SINGLE 2IN X 2IN |
| Generic Name | TENOGLIDE |
| Product Code | JXI |
| Date Received | 2011-06-21 |
| Catalog Number | TG221 |
| Lot Number | 105A00193691 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, PLAINSBORO |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-06-21 |