MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-12-17 for BONE WAX UNK manufactured by Ethicon Inc..
[33800287]
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
Patient Sequence No: 1, Text Type: N, H10
[33800288]
It was reported that a patient underwent a bunionectomy procedure on both feet with removal of a boney prominence of the fifth toe in (b)(6) 2015 and bone wax was used. Post operatively, the patient developed an allergic reaction with swelling of the foot and leg. The patient was seen by infectious disease and hospitalized for suspected osteomyelitis and treated with iv antibiotics. Osteomyelitis was ruled out. The patient underwent an mri and blood work and all have been negative. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2015-20758 |
| MDR Report Key | 5307666 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-12-17 |
| Date of Report | 2015-12-04 |
| Date Mfgr Received | 2015-12-04 |
| Date Added to Maude | 2015-12-17 |
| 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 | GUILLERMO VILLA |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Manufacturer G1 | UNKNOWN |
| Manufacturer Street | UNKNOWN |
| Manufacturer City | X |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE WAX |
| Product Code | MTJ |
| Date Received | 2015-12-17 |
| Model Number | UNK |
| Catalog Number | UNK |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2015-12-17 |