MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-12-03 for BONE WAX UNK W31G manufactured by Ethicon Inc..
[32615411]
(b)(4). Conclusion: to date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Patient Sequence No: 1, Text Type: N, H10
[32615412]
It was reported that the patient underwent a craniotomy procedure on unknown date and bone wax was used. It was also reported that the use of bone wax resulted in post- operative brain bleeds requiring additional surgery. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[34588284]
It was reported that the patient underwent a craniotomy procedure on unknown date and bone wax was used for control of bone bleeding and to seal air cells in the petrous bone to reduce chance of csf leak. It was also reported by the doctor that no brain bleed occurred. The doctor opined that the re-operation to repair csf leak was required due to the sub-optimal adherence of the wax to the bone and its failure to stay in place allowing the csf leak to occur. At the time of re-operation the previously placed bone wax was dry, brittle, loosely attached to the bone. The patient is doing well currently. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39990778]
Conclusion : representative sample was returned for evaluation. It was visually and functionally examined for wax adhesion and consistency and it met the requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2015-19512 |
| MDR Report Key | 5264460 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-12-03 |
| Date of Report | 2015-11-13 |
| Date Mfgr Received | 2016-02-19 |
| Device Manufacturer Date | 2015-05-30 |
| Date Added to Maude | 2015-12-03 |
| 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 | GUILLERMO VILLA |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Manufacturer G1 | ETHICON INC.-BRAZIL |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA, KM 1 54 |
| Manufacturer City | SAO PAOLO 12240-908 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 12240-908 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE WAX |
| Generic Name | WAX, BONE |
| Product Code | MTJ |
| Date Received | 2015-12-03 |
| Returned To Mfg | 2015-12-02 |
| Model Number | UNK |
| Catalog Number | W31G |
| Lot Number | AA3567 |
| 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 | 1. Required No Informationntervention | 2015-12-03 |