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 2018-11-06 for BONE WAX 2.5GRAMS W31C manufactured by Ethicon Inc..
[126274089]
Product complaint # (b)(4). 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. The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Patient Sequence No: 1, Text Type: N, H10
[126274090]
It was reported that a patient underwent a surgical procedure on an unknown date and bone wax was used. During the procedure, the bone wax would not stick to the bone. There were no adverse patient consequences reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-76966 |
| MDR Report Key | 8042646 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-06 |
| Date of Report | 2018-10-10 |
| Date Mfgr Received | 2018-10-10 |
| Device Manufacturer Date | 2017-05-09 |
| Date Added to Maude | 2018-11-06 |
| 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 | 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. |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA KM 154 |
| Manufacturer City | SAO PAOLO 12240-908 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 12240-908 |
| 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 | 2018-11-06 |
| Catalog Number | W31C |
| Lot Number | AH9563 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-11-06 |