MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05,07 report with the FDA on 2014-05-13 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corp..
[4395231]
It was reported as part of a study conducted titled: (b)(4), the patient is a (b)(6) female who rec'd integra on (b)(6) 2012. During the same admission the patient rec'd negative pressure wound therapy (npwt) and a local flap. The patient's wound was on the right lateral ankle, and was a result of surgical resection of neuroendocrine cancer. On (b)(6) 2012 the patient returned to the hospital for a split thickness skin graft (stsg) with npwt. On (b)(6) 2012, the target wound was deemed healed during a f/u visit. The wound recurred (b)(6) 2013. This event of dehiscence was documented as moderate in severity, probably related to the initial index treatment with integra, and considered not a serious event. The action taken was a stsg over hypergranulating area of dehiscence on (b)(6) 2013. The wound was deemed healed again on (b)(6) 2013 and the event was listed as resolved on (b)(6) 2013 , when the patient returned for a f/u visit. Add'l info was requested.
Patient Sequence No: 1, Text Type: D, B5
[11894394]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2014-00016 |
| MDR Report Key | 3835908 |
| Report Source | 02,05,07 |
| Date Received | 2014-05-13 |
| Date of Report | 2014-04-18 |
| Date Mfgr Received | 2014-04-18 |
| Date Added to Maude | 2014-05-29 |
| 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 | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | MDD |
| Date Received | 2014-05-13 |
| Catalog Number | XXX-IDRT |
| 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 LIFESCIENCES CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-13 |