MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-12 for IDRT-TS 8X10 SINGLE DOMESTIC 38101 manufactured by Integra Lifesciences Corporation.
[127872235]
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
[127872236]
2 of 2 reports - other mfg report number: 1121308-2018-00095. It was reported that the patient had idrt applied to bilateral feet on (b)(6) 2018 due to a burn injury. On the right foot the product was removed a few days after application due to non-adherence. Specific day of removal was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00096 |
| MDR Report Key | 8060874 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-12 |
| Date of Report | 2018-10-15 |
| Date Mfgr Received | 2018-11-02 |
| Date Added to Maude | 2018-11-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT-TS 8X10 SINGLE DOMESTIC |
| Generic Name | IDRT-TS |
| Product Code | MDD |
| Date Received | 2018-11-12 |
| Catalog Number | 38101 |
| Lot Number | 2282097 |
| Device Expiration Date | 2019-06-30 |
| 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 LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-12 |