MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for DYND70800 manufactured by Medline Industries Inc..
[138288408]
It was reported that the surgical clipper charging base "burnt up. " at the time of the incident, the charging base was reportedly plugged into a wall socket of an emergency department (ed) room and charging a surgical clipper handle. Reportedly, staff members at the facility identified smoke coming from the charging base and a "burning smell. " when the charging base issue was identified, it was unplugged and removed from the ed. There was no impact or adverse effect to a patient, a staff member, or a procedure in relation to the reported incident. Although no sample was returned to the manufacturer for evaluation, photos were provided. Visual inspection of the photos identified charring and residual ash on the charging base where the cord is located. This area was also identified to be blackened and singed. The reported lot number was confirmed to be part of a corrective action in 2015. It is unknown how or why the surgical clipper charging base was at the facility. Due to the reported incident, 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
[138288409]
It was reported that the surgical clipper charging base "burnt up. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00024 |
| MDR Report Key | 8396913 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-03-06 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-03-06 |
| 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 | 2019-03-06 |
| Catalog Number | DYND70800 |
| Lot Number | 13K1 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-03-06 |