MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-26 for DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 202050 manufactured by Integra Lifesciences Corporation.
[139813474]
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
[139813475]
A sales representative reported in behalf of the customer that the 202050 duraseal dural sealant system 5ml expanded five times of its original size that caused cauda equina syndrome. The date of the event was not specified. Revision/medical intervention was required. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00006 |
| MDR Report Key | 8451276 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-04 |
| Date Mfgr Received | 2019-04-24 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2019-03-26 |
| 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 CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| 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 | 2019-03-26 |
| Catalog Number | 202050 |
| Lot Number | N8A1127X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-26 |