MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-07 for DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 202050 manufactured by Integra Lifesciences Corp.
[140002951]
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
[140002952]
A customer reported that on (b)(6) 2019, the 202050 duraseal dural sealant was defective when the customer went to apply the product on the patient. There was no patient injury. The product problem led to a couple minutes delay just to get another product. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00003 |
| MDR Report Key | 8399255 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-07 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-02-13 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-03-07 |
| 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 | 2019-03-07 |
| Catalog Number | 202050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-03-07 |