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 2019-03-06 for BONE WAX 2.5GRAMS W31C manufactured by Ethicon Inc..
[137991275]
Product complaint # (b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. The single complaint was reported with multiple events. There are no additional details regarding the additional patient events. Attempts are being made to obtain the following information and the following was obtained: it was reported that this event occurred in multiple procedures, please provide the following information: what is the total number of procedures? As per event description, approx 6-8 case a week where bone wax is used and customer is complaining about the product. Have any of these events been previously reported to ethicon? If so, provide the respective reference number(s). As per event description it has been logged under another complaint file. What are the procedure name(s) and date(s)? Dates not provided, these are used in cardiac procedures. Was there any adverse patient consequence(s) or subsequent medical/surgical intervention? None as of yet. They have refused to continue using w31c, in order to prevent an adverse reaction from occurring. Are these bone wax opened at the beginning of the procedure and left there until they need to use it? Or are they opened when it? S required during the procedure? Opened as customer need them. However there are times that we opened as we know we will use for bigger children. Attempts have been 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
[137991276]
It was reported a patient underwent an unknown cardiac surgery on an unknown date and bone wax was used. The wax is crumbling. No adverse patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-79311 |
| MDR Report Key | 8395486 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-06 |
| Date of Report | 2019-02-11 |
| Date Mfgr Received | 2019-02-11 |
| Device Manufacturer Date | 2018-04-20 |
| Date Added to Maude | 2019-03-06 |
| 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. BRAZIL |
| 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 | 2019-03-06 |
| Catalog Number | W31C |
| Lot Number | AK5709 |
| 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 | 2019-03-06 |