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 2013-06-13 for IDRT - TS (INTL) SINGLE 4X5 84051 manufactured by Tintegra Lifesciences Corp..
[15012894]
It was reported the patient was enrolled in a clinical study in france titled: evaluation of integra artificial dermis for the treatment of leg ulcers. Idrt was implanted on (b)(6) 2011 on the heel of the patient's right foot followed by a skin graft on (b)(6) 2011. The wound (initially) healed, but the right heel would reopened on (b)(6) 2012 with a 4mm x 4mm ulceration, bone contact and serous flow osteitis. A bone scan and a scan with positive leukocyte marker were done which showed polynuclear concentration on the posterior lateral part of the patient's heel (local infection). Hospitalization was required. Cultures were obtained during a free flap surgery performed on (b)(6) 2013 followed by a cutaneous graft on (b)(6) 2013. The patient received antibiotic (unspecific) treatment from (b)(6) 2013. On (b)(6) 2013 the patient's current condition was reported as "the flap surgery worked and everything is ok. "
Patient Sequence No: 1, Text Type: D, B5
[15460834]
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 | 1121308-2013-00022 |
| MDR Report Key | 3179579 |
| Report Source | 01,02,05,07 |
| Date Received | 2013-06-13 |
| Date of Report | 2013-06-13 |
| Date Mfgr Received | 2013-06-04 |
| Date Added to Maude | 2013-06-21 |
| 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 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 | 2013-06-13 |
| Catalog Number | 84051 |
| Lot Number | 105C00221141 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TINTEGRA LIFESCIENCES CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-06-13 |