MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2017-08-25 for BONE WAX BONEWAXUNK manufactured by Ethicon Inc..
[83654579]
(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. No specific patient information regarding events has been provided. 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. Were the cases discussed in this article previously reported to ethicon? If yes, please provide a complaint reference number. Does the surgeon believe that ethicon products / bone wax involved caused and /or contributed to the adverse events described in the article, specifically: adhesions, foreign body reaction, inflammation? If yes, provide details of event and specific suture product type. Can specific patient demographics be provided for each of the subjects of this article? If yes, please include:
Patient Sequence No: 1, Text Type: N, H10
[83654580]
It was reported in a journal article that the patient underwent femoral acetabular impingement surgery on an unknown date and bone wax was used. During revision procedure, the patient possibly experienced foreign body-type chronic synovial inflammation, lymphoplasmacytic inflammatory reaction. It was also reported that the patient may have experienced capsular adhesions and possible additional disorders. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2017-70076 |
| MDR Report Key | 6820810 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2017-08-25 |
| Date of Report | 2017-08-03 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-08-25 |
| 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 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA KM 154 |
| Manufacturer City | SAO PAOLO |
| Manufacturer Country | BR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE WAX |
| Generic Name | WAX, BONE |
| Product Code | MTJ |
| Date Received | 2017-08-25 |
| Catalog Number | BONEWAXUNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-25 |