MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-20 for RECHARGEABLE SURGICAL CLIPPER 5513E manufactured by Carefusion, Inc.
[73330612]
(b)(4) - should the device become available, a follow-up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[73330613]
A patient that was clipped in pre op yesterday. The nurses in pre op had no indication that the patients? Stretch marks? On the upper abdomen would abrade so terribly, as a matter of fact, they report that this was not visible during or immediately following the clipping, or they would have stopped clipping and reported the abrasions to the surgeon. The skin was visibly abraded with bleeding noted once the patient was in the or. Sample is unavailable. Bacitracin required on abrasions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004932373-2017-00011 |
| MDR Report Key | 6509064 |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-02-08 |
| Date Added to Maude | 2017-04-20 |
| 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 | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RECHARGEABLE SURGICAL CLIPPER |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2017-04-20 |
| Model Number | 5513E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-20 |