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) SINGLE 4X5 84051 manufactured by Integra Lifesciences Corp..
[3085579]
The reporter noted the pt was enrolled in a clinical study in (b)(6) titled: "eval of integra artificial dermis for the treatment of leg ulcers. The pt underwent implantation of idrt on (b)(6) 2011, on a mixed ulcer. The pt developed a local infection on (b)(6) 2011, under the silicone (positive for pseudomonas "aerugosima" and e coli). Antibiotic treatment and washing were provided. The infection subsided on (b)(6) 2011. The pt developed a new infection on (b)(6) 2011, with lysis of the graft at 80%. Treatment was provided with a different dressing.
Patient Sequence No: 1, Text Type: D, B5
[10435802]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2012-00032 |
| MDR Report Key | 2802358 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT-TS (INTL) SINGLE 4X5 |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2012-10-19 |
| Catalog Number | 84051 |
| Lot Number | 105C00207932 |
| 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 |