MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-19 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corporation.
[139181417]
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
[139181418]
A sales representative reported that on (b)(6) 2019 the idrt was not released on time and the operating room did not have the product for the surgery. The operating room had to continue without the idrt and the patient was not optimally treated. It is not possible to determine if there will be further complications after the surgery or during treatment. Patient injury was reported and the event lead to surgical delay, unknown for how long. Additional information received: surgeon says that there was no issue with the delay. During the operation he realized that he could not use the idrt because the wound situation changed. Nothing went wrong, only the delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2019-00005 |
| MDR Report Key | 8431923 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-19 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-02-22 |
| Date Mfgr Received | 2019-02-22 |
| Date Added to Maude | 2019-03-19 |
| 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, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | MDD |
| Date Received | 2019-03-19 |
| Catalog Number | XXX-IDRT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-03-19 |