MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-11 for DYND70800 manufactured by Medline Industries Inc..
[82668199]
It was reported a surgical clipper base sparked and flamed. End-user heard a buzzing noise and saw sparks and flames coming from the clipper. The clipper was unplugged from the wall; sparking and flame stopped. No serious injury occurred and no medical intervention was required. It was determined the device was part of a recall in 2015. It is unclear why the end-user had possession of the recalled clipper. Due to the reported incident and in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[82668200]
It was reported a surgical clipper base sparked and flamed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00063 |
| MDR Report Key | 6787622 |
| Date Received | 2017-08-11 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-07-28 |
| Date Mfgr Received | 2017-07-31 |
| Date Added to Maude | 2017-08-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN DEBUS |
| 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 | SURGICAL CLIPPER CHARGER BASE |
| Product Code | LWK |
| Date Received | 2017-08-11 |
| Catalog Number | DYND70800 |
| Lot Number | 14C1 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-08-11 |