MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-18 for SURGICAL CLIPPER BLADE (FOR GENERAL USE) 4406 manufactured by Carefusion, Inc.
[111349562]
Initial mdr submission, a follow up will be submitted if additional information becomes available. (b)(4). *oem is (b)(4), however that information was not available to bd; for this reason carefusion has been listed as the reporting office and manufacturing site.
Patient Sequence No: 1, Text Type: N, H10
[111349563]
We regularly have injured patients when shaving with surgical clippers ( blade reference 4406 ) would it be possible to provide information/training to the teams?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00381 |
| MDR Report Key | 7610093 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-18 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-05-04 |
| Date Mfgr Received | 2018-05-04 |
| Date Added to Maude | 2018-06-18 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 NORTH FAIRWAY 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 | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL CLIPPER BLADE (FOR GENERAL USE) |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2018-06-18 |
| Catalog Number | 4406 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| 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. Required No Informationntervention | 2018-06-18 |