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 2018-11-28 for DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED 203001 manufactured by Integra Lifesciences Corp.
[129451016]
It is unknown if the device will 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
[129451017]
A distributor reported on behalf of the customer that the 203001 duraseal spine ous 3ml kit was used on (b)(6) 2018 for an unspecified procedure. It was reported that the gel was not formed when it was sprayed over the area; it was like water. The scrub sister said there was nothing wrong with the powder. The device was in contact with the patient but the patient was not injured. The event did not lead to an increase in surgery time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00044 |
| MDR Report Key | 8111137 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-11-06 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2018-07-11 |
| Date Added to Maude | 2018-11-28 |
| 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 SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED |
| Generic Name | DURASEAL SPINE |
| Product Code | NQR |
| Date Received | 2018-11-28 |
| Returned To Mfg | 2018-11-13 |
| Catalog Number | 203001 |
| Lot Number | 60137689 |
| 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 | 2018-11-28 |