MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2017-12-01 for SURGICAL CLIPPER BLADE 4406 manufactured by Carefusion, Inc.
[93482213]
Pr (b)(4) emdr initial submitted. If additional information is needed, a follow up will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[93482214]
The clipper blades rupture the patient's skin. This delayed the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004932373-2017-00111 |
| MDR Report Key | 7075363 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2017-12-01 |
| Date of Report | 2018-02-08 |
| Date of Event | 2017-10-16 |
| Date Mfgr Received | 2017-10-16 |
| Date Added to Maude | 2017-12-01 |
| 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 | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL CLIPPER BLADE |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2017-12-01 |
| Catalog Number | 4406 |
| Lot Number | 0117 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-01 |