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 2013-06-17 for IDRT-TS (INTL) 5 PACK 4X5 84055 manufactured by Integra Lifesciences Corp..
[3557908]
It was reported the pt was enrolled in a clinical study in (b)(4) titled: eval of integra artificial dermis for the treatment of leg ulcers. Idrt was implanted on (b)(6) 2012 on the pt's left posterior leg ulcer. On (b)(6) 2012, the graft was checked and a localized infection (acinetobacter which was multi-resistant) was observed. Treatment with (unspecified) antibiotics was provided and the infection resolved "due to antibiotics".
Patient Sequence No: 1, Text Type: D, B5
[10858950]
Integra has completed their internal investigation on (b)(4) 2013. The investigation included: methods: review of device history records. Review of complaint history. Eval of the complaint related device was not performed as the product was not returned. A review of the mfg records was performed which revealed: all mfg equipment underwent sterilization at the required temp and time conditions. The foil and tyvek pouch sealing conditions and test results were reviewed and met requirements. Product endotoxin and pre-sterile bioburden tests met requirements. Environmental monitoring results met requirements. The product lots terminal sterilization results were reviewed and the radiation doses met requirements. All finished good requirement were satisfactorily met. Therefore, based on the dhr review conducted, there is no indication that the production process may have contributed to this complaint. Review of complaint history: there were 15 infection related complaints for idrt-ts, idrt-sl, bmw and mwm skin products in the previous 12 months. None of these other complaints involved the lot genealogy of this complaint. (b)(4). Note that there were no other complaints associated with this lot genealogy; this complaint appears to be an isolated event. Conclusion: based on review of the batch record, nonconformances, trending and complaint history, no root cause attributable to the mfg process could be identified through this investigation. In addition, the product was not returned from the field; therefore, no failure analysis of the product could be conducted. Based on the reported info and the investigation results provided. Integra considers this complaint closed. Future incidents of this nature will be documented for recurrence and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00019 |
| MDR Report Key | 3181508 |
| Report Source | 01,02,05,07 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-06-17 |
| Date Mfgr Received | 2013-05-23 |
| Date Added to Maude | 2013-06-24 |
| 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) 5 PACK 4X5 |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2013-06-17 |
| Catalog Number | 84055 |
| Lot Number | 105B00246903 |
| 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 | 2013-06-17 |