MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-01-13 for BONE WAX 2.5GRAMS W31C manufactured by Ethicon Inc..
[133058585]
Product complaint # (b)(4). A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Patient Sequence No: 1, Text Type: N, H10
[133058586]
It was reported that a patient underwent a craniotomy procedure (b)(6) 2019, and bone wax was used. The surgeon opened the bone wax to apply onto the skull to stop the bone bleeding. The bone wax did not stick on the bone. It was reported that the bone was softer than previous bone wax. Since the product didn? T adhere to the bone bleeding side, it didn't stop the bleeding. The surgeon then opened a pack of different batch of bone wax to apply on the bleeding side (skull). The procedure was completed successfully. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-78371 |
| MDR Report Key | 8243069 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-01-13 |
| Date of Report | 2018-12-16 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2017-10-19 |
| Date Added to Maude | 2019-01-13 |
| 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, |
| 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 | 2019-01-13 |
| Returned To Mfg | 2019-01-23 |
| Catalog Number | W31C |
| Lot Number | AJ7530 |
| 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 | 2019-01-13 |