MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for DYND70800 manufactured by Medline Industries Inc..
[134374969]
It was reported that the surgical clipper charging base experienced "melting. " reportedly, at the time of the incident, the base was plugged into an electrical socket inside of a procedure room and that there was no surgical clipper charging. A staff member noticed the reported "melting" during cleaning of the procedure room. The base was unplugged after this product issue was identified. No smoking, sparking, or fire reported. There was no patient inside of the procedure room at the time of the incident. There was no impact or adverse effect to a staff member related to this incident. No sample was returned to the manufacturer for evaluation. A root cause for the reported incident could not be determined. 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
[134374970]
It was reported that the surgical clipper charging base experienced "melting. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00008 |
| MDR Report Key | 8282399 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-29 |
| Date of Event | 2019-01-02 |
| Date Mfgr Received | 2019-01-02 |
| Date Added to Maude | 2019-01-28 |
| 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 | 2019-01-28 |
| Returned To Mfg | 2019-01-22 |
| Catalog Number | DYND70800 |
| Lot Number | 14G1 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-28 |