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 2013-06-11 for IDRT TS INTL 1PK 4X10 84101 manufactured by Integra Lifesciences Corp..
[3550605]
It was reported the patient was enrolled in a post market clinical study in (b)(6) titled (b)(4). Idrt was implanted on the patient's right leg (medial inferior aspect) on (b)(6) 2012. On (b)(6) 2012 an infection was observed. The patient was treated with (unspecified) antibiotic(s). Healing and resolution (of the infected) was on (b)(6) 2012. Additional information was requested by integra.
Patient Sequence No: 1, Text Type: D, B5
[10813606]
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 | 1121308-2013-00021 |
| MDR Report Key | 3167405 |
| Report Source | 01,02,05,07 |
| Date Received | 2013-06-11 |
| Date of Report | 2013-06-11 |
| Date Mfgr Received | 2013-05-23 |
| Date Added to Maude | 2013-06-14 |
| 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 1PK 4X10 |
| Generic Name | INTEGRA |
| Product Code | MDD |
| Date Received | 2013-06-11 |
| Catalog Number | 84101 |
| Lot Number | 105A00220443 |
| 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 | 2013-06-11 |