MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-10 for BLADE CLIPPER SURG 4406 manufactured by Carefusion, Inc.
[90312108]
(b)(4). - the adverse event occurred while the nurse was attempting to attach the blade to the handle stating that the blade is very hard to attach to the clipper because the plastic around the blade are very tiny. (b)(4) examined the handle and found this was caused by physical damage. The edge of driving shaft and? The parts for mounting the blade? Were broken by? Dropping to the hard floor. (b)(4) has never changed plastic material(pom and asa) of the clipper handle. Should further information be received, a follow-up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[90312109]
A nurse did cut her finger when she had to place the blade on the clipper. The blade is very sharp on the inside and is not protected at all, this is where the accident occurred. (in comparison the neuro blades and sensi blades are both protected at the inner side ). In addition, they mentioned that the blade is very hard to attach to the clipper because the plastic around the blade are very tiny.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2017-00103 |
| MDR Report Key | 6937659 |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-09-12 |
| Date Mfgr Received | 2017-09-12 |
| Date Added to Maude | 2017-10-10 |
| 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 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLADE CLIPPER SURG |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2017-10-10 |
| Returned To Mfg | 2017-10-05 |
| Model Number | 4406 |
| Lot Number | 0816 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-10-10 |