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 2019-03-19 for DURASEAL 5ML 1 KIT/BOX CE APPROVED DSD5001 manufactured by Integra Lifesciences Corp.
[139201150]
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
[139201151]
A quality coordinator reported on behalf of the customer that the dsd5001 duraseal 5ml 1 kit/box blue precursor was mixed into the powder vial and when it was drawn back, it was noted that the volume available to draw back was only 1. 5 milliliter (ml). The date of the incident was on (b)(6) 2019. There was patient contact but there was no patient injury or surgery delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00005 |
| MDR Report Key | 8432222 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-19 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-09-30 |
| Device Manufacturer Date | 2018-07-19 |
| Date Added to Maude | 2019-03-19 |
| 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 | MRS. KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362319 |
| 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 5ML 1 KIT/BOX CE APPROVED |
| Generic Name | DURASEAL CRANIAL |
| Product Code | NQR |
| Date Received | 2019-03-19 |
| Catalog Number | DSD5001 |
| Lot Number | N8G0233X |
| 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 | 2019-03-19 |