MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for DYND70800 manufactured by Medline Industries Inc..
[135084038]
It was reported that the surgical clipper's charger overheated and caught fire. Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details. Per the lot number provided, this surgical clipper was part of a corrective action that took place in 2015 and it was confirmed that the facility acknowledged this corrective action. No impact to a patient, staff, or procedure was originally reported. There was no serious injury, medical intervention, or follow-up care reported related to the event. Due to the reported incidence of fire, this medwatch is being filed. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[135084039]
It was reported that the surgical clipper's charger overheated and caught fire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00012 |
| MDR Report Key | 8302269 |
| Date Received | 2019-02-04 |
| Date of Report | 2019-02-04 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2019-02-04 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| 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 | 2019-02-04 |
| Catalog Number | DYND70800 |
| Lot Number | 14C1 |
| 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 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-04 |