MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-05-18 for IDRT SINGLE LAYER (INTL) 2X2 SINGLE 62021 manufactured by Integra Lifesciences Corporation.
[108639535]
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
[108639536]
It was reported two patients with delayed seroma under the integra idrt, both elderly trauma female patients. Surgeon is suturing the idrt and patients are non-weight bearing for the first week. Second case: around the ankle, part periosteum and part tendon, a seroma happened few days after removing the negative pressure dressing. He only use continuous setting, he managed to save the second graft and express the seroma didn't recur in this patient. The 2 of 2 reports - other mfg report number: 1121308-2018-00024.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00025 |
| MDR Report Key | 7525469 |
| Report Source | FOREIGN |
| Date Received | 2018-05-18 |
| Date of Report | 2018-05-01 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2018-05-18 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SONIA IRIZARRY |
| 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 SINGLE LAYER (INTL) 2X2 SINGLE |
| Generic Name | IDRT |
| Product Code | MDD |
| Date Received | 2018-05-18 |
| Catalog Number | 62021 |
| 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 | 1. Other | 2018-05-18 |