MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,07 report with the FDA on 2012-10-19 for IDRT-TS (INTL) 5 PACK 4X5 84055 manufactured by Integra Lifesciences Corp..
[15423986]
The reporter noted the patient was enrolled in a clinical study in (b)(6) titled: "evaluation of the integra artificial dermis for the treatment of leg ulcers. Implantation of idrt was on (b)(6) 2012 on a mixed ulcer (bacteriologic sampling on (b)(6) 2012 positive with some (b)(6). On (b)(6) 2012 the patient developed a "local infection and flow under the silicone" and underwent wound care surgery on (b)(6) 2012 and a skin graft on (b)(6) 2012. The patient's wound has not healed yet. The patient is under treatment. "
Patient Sequence No: 1, Text Type: D, B5
[15753808]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2012-00034 |
| MDR Report Key | 2802353 |
| Report Source | 01,02,05,07 |
| Date Received | 2012-10-19 |
| Date of Report | 2012-10-19 |
| Date Mfgr Received | 2012-09-27 |
| Date Added to Maude | 2012-10-25 |
| 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 FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT-TS (INTL) 5 PACK 4X5 |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2012-10-19 |
| Catalog Number | 84055 |
| Lot Number | 105D00221141 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-10-19 |