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 2019-04-01 for BONE WAX 2.5GRAMS W31C manufactured by Ethicon Inc..
[140434520]
(b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. Attempts are being made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[140434521]
It was reported that a patient underwent an unknown neurological procedure on an unknown date and bone wax was used. During the procedure, the bone wax was not sticking to the bone. As they were applying it, it was simply coming off as they move along the bone. The procedure was completed with a different device. There were no adverse patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-79829 |
| MDR Report Key | 8468898 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-01 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-04-11 |
| Device Manufacturer Date | 2018-09-10 |
| Date Added to Maude | 2019-04-01 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC.-BRAZIL |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA KM 154 |
| Manufacturer City | SAO PAOLO |
| Manufacturer Country | BR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE WAX 2.5GRAMS |
| Generic Name | WAX, BONE |
| Product Code | MTJ |
| Date Received | 2019-04-01 |
| Returned To Mfg | 2019-04-08 |
| Catalog Number | W31C |
| Lot Number | AL1661 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-01 |