MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-17 for DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5 206520 manufactured by Integra Lifesciences Corp.
[139068362]
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
[139068363]
A sales representative reported on behalf of the customer that the 206520 duraseal exact spine sealant system 5ml was prepared and when the physician tried to place the product in the patient but the mixture was not made; it came out totally liquid. The date of the event was not specified. There was patient contact but no patient injury noted. Revision/medical intervention was required but was not specified. There was a fifteen-minute delay in surgery due to the product problem. Additional information has been requested but no other clinical information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00004 |
| MDR Report Key | 8427325 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-17 |
| Date of Report | 2019-02-22 |
| Date Mfgr Received | 2019-04-05 |
| Device Manufacturer Date | 2018-10-24 |
| Date Added to Maude | 2019-03-17 |
| 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 EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5 |
| Generic Name | DURASEAL SPINE |
| Product Code | NQR |
| Date Received | 2019-03-17 |
| Catalog Number | 206520 |
| Lot Number | N8K02948 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-17 |