MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-04 for DURASEAL XACT, UNKNOWN XXX-DURASEAL XACT manufactured by Integra Lifesciences Corp.
[140906374]
The device is not expected to be returned to the manufacturer for analysis. 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
[140906375]
A female patient reported that her doctor used? A lot? Of duraseal product during spinal surgery on (b)(6) 2019. The doctor did not specify an amount used. The exact product id of the duraseal was not known; not sure if the 3ml (206320) or 5ml (206520). The patient stated she was in extreme pain and had trouble walking or standing. The date of the event was not specified. The patient was seeking to know how long it takes for the product to absorb into her body as the pain was unbearable. Additional information has been requested but no other clinical information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00008 |
| MDR Report Key | 8482352 |
| Report Source | CONSUMER |
| Date Received | 2019-04-04 |
| Date of Report | 2019-03-12 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-04-04 |
| 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 CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| 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 | 2019-04-04 |
| Catalog Number | XXX-DURASEAL XACT |
| 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 | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-04 |