MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2018-11-20 for DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 202050 manufactured by Integra Lifesciences Corp.
[129181901]
The device was not yet 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
[129181902]
A regulatory affairs specialist reported on behalf of the customer that the gel of the 202050 duraseal dural sealant did not work as a sealant on the target site as it was sucked up by the suction tube. The user assembled the duraseal kit as per instructions for use. The sealant was applied on a (b)(6) male with no noted injury. No medical revision was conducted. There was a surgery delay of 20 minutes and the team used another duraseal kit to finish the procedure. Additional information was received on 31oct2018 stating that the date of incident was on (b)(6) 2018 and the duraseal was used for a craniofacial resection surgery. The time of surgery delay had no impact on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00043 |
| MDR Report Key | 8088989 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2018-11-20 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-20 |
| 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 DURAL SEALANT SYSTEM 5ML US BOX OF 5 |
| Generic Name | DURASEAL CRANIAL |
| Product Code | NQR |
| Date Received | 2018-11-20 |
| Returned To Mfg | 2018-11-20 |
| Catalog Number | 202050 |
| Lot Number | N8A0466X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-20 |