MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for STANDARD PREP BLADE CAH4406D manufactured by Cardinal Health 200, Llc.
[181361780]
While prepping patient left hip for surgery utilizing surgical clippers, patient stated he was feeling as if he was being pinched. I immediately stopped usage of clippers and examined site. Noted abrasion to hip. Removed single use clipper and stored in biohazard bag. Retrieved new clipper and attached to battery handle. Proceeded to complete prep of left hip and patient tolerated well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9769152 |
| MDR Report Key | 9769152 |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-05 |
| Report Date | 2020-02-26 |
| Date Reported to FDA | 2020-02-26 |
| Date Reported to Mfgr | 2020-02-28 |
| Date Added to Maude | 2020-02-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD PREP BLADE |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2020-02-28 |
| Model Number | CAH4406D |
| Catalog Number | CAH4406D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |