MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-05-02 for BONE WAX BW25G manufactured by Sofradim Production Sas.
[143931948]
(b)(4). Title: an unusual complication of bone wax utilization source: the journal of craniofacial surgery, volume 29, 2018 (976? 979) article number: 4 date of publication: 16 november 2017. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143931949]
According to the literature, patient who initially underwent craniotomy for the evacuation of subdural hematoma and repair of depressed skull fracture, bone wax was migrated intracranially. Postoperatively, patient developed short-term memory loss, apraxia, and word finding difficulties. The imaging findings were consistent with the presence of a foreign body centered in the posterior aspect of the left middle temporal gyrus, which was surgically removed and found to be bone wax.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615742-2019-01592 |
| MDR Report Key | 8575833 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-02 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-05-02 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | SOFRADIM PRODUCTION SAS |
| Manufacturer Street | 116 AVENUE DU FORMANS |
| Manufacturer City | TREVOUX 01600 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 01600 |
| 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 | 2019-05-02 |
| Model Number | BW25G |
| Catalog Number | BW25G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFRADIM PRODUCTION SAS |
| Manufacturer Address | 116 AVENUE DU FORMANS TREVOUX 01600 FR 01600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-02 |