MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-06-17 for DURAGEN-UNKNOWN PRODUCT ID XXXDUR manufactured by Integra Lifesciences Corp.
Report Number | 1121308-2019-00012 |
MDR Report Key | 8705204 |
Report Source | HEALTH PROFESSIONAL,LITERATUR |
Date Received | 2019-06-17 |
Date of Report | 2019-05-28 |
Date Mfgr Received | 2019-05-28 |
Date Added to Maude | 2019-06-17 |
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 | DURAGEN-UNKNOWN PRODUCT ID |
Generic Name | PLAINSBORO |
Product Code | GXQ |
Date Received | 2019-06-17 |
Catalog Number | XXXDUR |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
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 | 2019-06-17 |