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) SINGLE 2X2 82021 manufactured by Integra Lifesciences Corp.
[3548658]
It was reported "the pt was enrolled in a post market clinical study in (b)(6) titled (b)(4). Implantation with idrt was on (b)(6) 2012. Bleeding was noted "under silicone 2 days after implantation of idrt with intensive pain difficult to stop even with medicine. The first dressing 2 days after implantation showed that the skin equivalent has a bad quality with beginning of infection (green color of the skin equivalent, perilesional skin with important inflammation". The pain continued and (there was) local inflammation, which lead to a second surgery on (b)(6) 2012: (the surgeon) took off staple, silicone and washed with physiological solution and dermic betadine. Then implantation of a second idrt was performed. A bacteriological sample was done during the surgery which detected (b)(6). Antibiotic treatment was implemented (dalacine 300 mg and oflocet 200 mg for 6 weeks). The pt was followed during the clinical study and the healing was complete on (b)(6) 2012". Additional information was requested and obtained for clarification "after 2 days as there is an infection the surgeon found the idrt with poor quality (green color and peri-lesional skin with important inflammation). This surgeon usually does sharp debridement or surgical excision of the wound site. "
Patient Sequence No: 1, Text Type: D, B5
[10873517]
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 | 1121308-2013-00017 |
| MDR Report Key | 3164356 |
| 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 | 0 |
| 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) SINGLE 2X2 |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2013-06-10 |
| Catalog Number | 82021 |
| Lot Number | 105C00205502 |
| 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 | 2013-06-10 |