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 2013-06-10 for IDRT-TS(INTL) 5 PACK 4X5 84055 manufactured by Integra Lifesciencs Corp.
[3539519]
It was reported the pt was enrolled in a clinical study in (b)(6) titled: (b)(4). Idrt was implanted on (b)(6) 2012 on an ulcer of the pt's right leg. On (b)(6) 2012 a localized infection was suspected and a "sampling" was performed that day. The results were received on (b)(6) 2012: positive (b)(6). Treatment was with (unspecified) antibiotics. The infection was resolved on (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[10838765]
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 | 1121308-2013-00016 |
| MDR Report Key | 3164355 |
| Report Source | 01,02,05,07 |
| Date Received | 2013-06-10 |
| Date of Report | 2013-06-10 |
| Date Mfgr Received | 2013-05-23 |
| Date Added to Maude | 2013-06-13 |
| 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-TS(INTL) 5 PACK 4X5 |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2013-06-10 |
| Catalog Number | 84055 |
| Lot Number | 105B00246903 |
| Device Expiration Date | 2014-04-30 |
| 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 LIFESCIENCS CORP |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-10 |