MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-20 for SURGICAL CLIPPER BLADE 4406 manufactured by Carefusion, Inc.
[111826172]
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
[111826173]
The patient had been shaved for a procedure to be performed in cathlab and was shaved in the required area with the bd carefusion clippers using the general shaving blade. The patient came to them and showed them that the blade had nicked him a few times. He then went to cathlab for his procedure where they proceeded to do the procedure. He was later released and asked if he could treat the nicks with bactroban as he had some at home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00441 |
| MDR Report Key | 7623246 |
| Date Received | 2018-06-20 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-05-21 |
| Date Mfgr Received | 2018-06-27 |
| Device Manufacturer Date | 2018-03-06 |
| Date Added to Maude | 2018-06-20 |
| 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 | 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 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURGICAL CLIPPER BLADE |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2018-06-20 |
| Returned To Mfg | 2018-05-21 |
| Catalog Number | 4406 |
| Lot Number | 0117 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Other; 2. Required No Informationntervention | 2018-06-20 |