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 2019-09-06 for BONE WAX 2.5GR W810 manufactured by Ethicon Inc..
Report Number | 2210968-2019-86684 |
MDR Report Key | 8971950 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-09-06 |
Date of Report | 2019-08-12 |
Date of Event | 2019-08-11 |
Date Mfgr Received | 2019-10-18 |
Device Manufacturer Date | 2018-04-01 |
Date Added to Maude | 2019-09-06 |
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 | KARA DITTY-BOVARD |
Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
Manufacturer City | SOMERVILLE NJ 088760151 |
Manufacturer Country | US |
Manufacturer Postal | 088760151 |
Manufacturer Phone | 6107428552 |
Manufacturer G1 | ETHICON INC.-AURANGABAD INDIA |
Manufacturer Street | 312379@B-15/1, M.I.D.C. 1 WALU |
Manufacturer City | AURANGABAD |
Manufacturer Country | IN |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | BONE WAX 2.5GR |
Generic Name | WAX, BONE |
Product Code | MTJ |
Date Received | 2019-09-06 |
Returned To Mfg | 2019-08-30 |
Catalog Number | W810 |
Lot Number | B8036 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ETHICON INC. |
Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-09-06 |