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 2016-05-27 for BONE WAX UNK W810T manufactured by Ethicon Inc..
[46069245]
(b)(4). 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. 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. Return complaint device for evaluation, clarify reported procedure date, clarify event date reported.
Patient Sequence No: 1, Text Type: N, H10
[46069246]
It was reported that the patient underwent an unknown neuro procedure on unknown date and a bone wax was used. During process of spreading, the bone wax did not occlude bony bleeders and tended to fall out of bony vessels. The procedure completed with another like device. There were no adverse patient consequence reported. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[48516414]
A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. 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
[58827677]
The returned unopened / sterile sample was chemically analyzed and all test results met the specified quality requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2016-09276 |
| MDR Report Key | 5684625 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-05-27 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-02-06 |
| Date Mfgr Received | 2016-10-07 |
| Device Manufacturer Date | 2015-12-01 |
| Date Added to Maude | 2016-05-27 |
| 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.-UK |
| Manufacturer Street | SIMPSON PARKWAY, KIRKTON CAMPU S |
| Manufacturer City | LIVINGSTON |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE WAX |
| Generic Name | STERILE NONABSORBABLE BONE WAX |
| Product Code | MTJ |
| Date Received | 2016-05-27 |
| Returned To Mfg | 2016-10-06 |
| Model Number | UNK |
| Catalog Number | W810T |
| Lot Number | JP5CDLM |
| 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 | 2016-05-27 |