MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-11 for DYNJBW25 manufactured by Medline Industries Inc..
[110641176]
It was reported that at the beginning of a sternotomy procedure a piece of the bone wax broke off into the surgical site. Reportedly, the surgeon was required to remove the bone wax from the surgical site via an unidentified method. The patient was under general anesthesia at the time of the incident. The procedure did not last longer than expected and the patient did not require additional anesthesia to complete the procedure. No impact to the patient reported. No impact to the procedure reported. No sample was returned to the manufacturer for evaluation. No additional information was provided to the manufacturer. Due to the need for medical intervention to remove the bone wax from the surgical site, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[110641177]
It was reported that at the beginning of a sternotomy procedure a piece of the bone wax broke off into the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00051 |
| MDR Report Key | 7586478 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-11 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-05-24 |
| Date Added to Maude | 2018-06-11 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WAX,BONE,NATURAL |
| Product Code | MTJ |
| Date Received | 2018-06-11 |
| Catalog Number | DYNJBW25 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-11 |