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 2019-04-30 for DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5 206520 manufactured by Integra Lifesciences Corp.
[143539793]
It is unknown if the device will be returned to the manufacturer for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Linked to mfg report number: 3003418325-2019-00012.
Patient Sequence No: 1, Text Type: N, H10
[143539794]
This is 1 of 2 reports. A sales representative reported on behalf of the customer that two (2) patients have received infections on (b)(6) 2019 after the 206520 duraseal exact spine sealant system was used for a neuro procedure. The infection was on the site of application. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00011 |
| MDR Report Key | 8564485 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-05-09 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2019-04-30 |
| 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 | 2019-04-30 |
| Catalog Number | 206520 |
| Lot Number | N8F0627 |
| 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 CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-30 |