MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-12 for DYND70800 manufactured by Medline Industries Inc..
[136282686]
It was reported that the surgical clipper charger and base caught fire. It is unknown how the surgical clipper charger and base was being used at the time of the incident. No impact or adverse effect to a patient, a staff member, or a procedure has been reported to the manufacturer. No sample was returned to the manufacturer for evaluation. Photos of the surgical clipper charger and base were submitted to the manufacturer. Visual inspection of the photos identified charring and residual ash on the surgical clipper base. The reported lot number was confirmed to be part of a corrective action that took place in 2015. It is unknown how or why the reported surgical clipper charger and base was at the facility. Due to the reported fire, and in an abundance of caution, this medwatch is being filed. If additional information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[136282687]
It was reported that the surgical clipper charger and base caught fire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00019 |
| MDR Report Key | 8333413 |
| Date Received | 2019-02-12 |
| Date of Report | 2019-02-12 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2019-02-12 |
| 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 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | CLIPPER, SURGICAL, CHARGER & BASE |
| Product Code | LWK |
| Date Received | 2019-02-12 |
| Catalog Number | DYND70800 |
| Lot Number | 14A1 |
| 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 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-12 |