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..
[134452295]
It was reported that the surgical clipper charging base "caught on fire. " reportedly, at the time of the incident, the base was already plugged into a wall socket of a procedure room. No surgical clipper was charging at the time of the incident. This incident occurred when the procedure room was not in use and there was no impact or adverse effect to a patient, staff member, or procedure related to the reported product issue. According to the reporting facility, there was no burning odor or smoke at the time of the incident. The fire was not witnessed but the base was found to have a "burn mark. " no sample has been returned to the manufacturer for evaluation. A root cause for the reported product issue 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
[134452296]
It was reported that the surgical clipper charging base "caught on fire. "
Patient Sequence No: 1, Text Type: D, B5
[134627479]
A sample of the surgical clipper charging base was returned to the manufacturer for evaluation on (b)(6) 2019 with investigation completed on (b)(6) 2019. Inspection of the returned sample identified a buildup of char where the cord comes out of the base with burn marks noted on the opposite side. The bottom of the base was opened and burn marks were also noted to the inside of the base. A photo was also submitted and visually inspected. The reported product problem was confirmed. A root cause could not be identified. If additional relevant information becomes available another supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2019-00009 |
| MDR Report Key | 8282374 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-29 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-01-08 |
| 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 | 2019-01-08 |
| Catalog Number | DYND70800 |
| Lot Number | 80516070001 |
| 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 |