MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-10-02 for DURASEAL XACT, UNKNOWN XXX-DURASEAL XACT manufactured by Integra Lifesciences Corporation.
[122309740]
The devices are not expected to be returned to the manufacturer for analysis; the customer threw them out. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[122309741]
The customer reported that on (b)(6) 2018, two (2) duraseal units were opened but they were "too liquid". The device was in contact with patient. There was no patient injury. The event led to an increase in surgery time of 10 minutes. Another unit had to be used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00042 |
| MDR Report Key | 7925427 |
| Report Source | FOREIGN |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-09-17 |
| Date Mfgr Received | 2018-10-31 |
| Device Manufacturer Date | 2018-07-10 |
| Date Added to Maude | 2018-10-02 |
| 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 KIMBERLY SHELLY |
| 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 | DURASEAL XACT, UNKNOWN |
| Generic Name | DURASEAL SPINE |
| Product Code | NQR |
| Date Received | 2018-10-02 |
| Catalog Number | XXX-DURASEAL XACT |
| Lot Number | N8G0019X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-10-02 |