MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-07-11 for BONE WAX UNK W31G manufactured by Ethicon Inc..
[49153855]
(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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Aside from leakage, what other quality issues has the customer experienced while using bonewax? If available provide detail. How many patient procedures has the customer experienced quality issues while using bonewax? For each patient event please provide the following information: procedure name/date. Product code/lot number. Any adverse patient consequences. During the procedure were there any adverse patient consequences? If so was there any surgical or medical intervention performed? Is the lot number of the bonewax used during the procedure available?
Patient Sequence No: 1, Text Type: N, H10
[49153856]
It was reported that the patient underwent an unknown procedure on unknown date and bonewax was used. During the procedure, the bonewax was not sticking where applied and it is leading to leaks. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2016-10284 |
| MDR Report Key | 5781981 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-07-11 |
| Date of Report | 2016-06-15 |
| Date Mfgr Received | 2016-06-15 |
| Date Added to Maude | 2016-07-11 |
| 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 | KENNETH CLARK |
| Manufacturer Street | ROUTE 22 WESTP O BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082183547 |
| 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 | 2016-07-11 |
| Model Number | UNK |
| Catalog Number | W31G |
| Lot Number | UNK |
| 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 | 2016-07-11 |