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 2018-12-26 for BONE WAX 2.5GRAMS W31C manufactured by Ethicon Inc..
[131408996]
Product complaint # (b)(4). Additional information was requested and the following was obtained: did the event occur during one or multiple patient procedures? Multiple, unknown how many procedures. If this event occurred in multiple procedures, please provide the following information: what is the total number of procedures? Was not provided by customer. Have any of these events been previously reported to ethicon? If so, provide the respective reference number(s). Have not reported to ethicon. First time rep have been advised by hospital. What are the procedure name(s) and date(s)? Not provided by customer. What is the quantity involved per procedure: not provided by customer. Was there any adverse patient consequence(s) or subsequent medical/surgical intervention? No adverse to patient reported. What is the product lot number(s)? Tba. 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
[131408997]
It was reported a patient underwent an unknown cardiac surgery on (b)(6) 2018, and bone wax was used. These current bone wax crumbles. No reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2018-78010 |
| MDR Report Key | 8196057 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-26 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2018-12-26 |
| 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 | 2018-12-26 |
| Returned To Mfg | 2019-03-07 |
| Catalog Number | W31C |
| Lot Number | AK3052 |
| 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 | 2018-12-26 |