MAUDE Adverse Event Report: CAREFUSION, INC SURGICAL CLIPPER BLADE (FOR GENERAL USE); RAZOR, SURGICAL

Model Number	4406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo was provided for the evaluation.Visual examination of the photo shows abrasions on the patient's skin which verifies the reported issue.Without the actual sample, a definitive root cause could not be confirmed as a defect of the clipper.Panasonic states the most probable root cause was caused by using the handle/blade with strong pressure to the skin, or by using the broken blade.A production record review for the batch/lot could not be completed as no information was available.An in-service was training was completed by the bd sales associate with the reporter's site.This failure will continue to be tracked and trended.
Event or Problem Description
It was reported that there has been an increase in clipper razor burns.Verbatim: indicates that they have seen an increase in clipper razor burns and asked for a refresher on proper and safe use for the staff who clips patients prior to surgery.

• Brand Name: SURGICAL CLIPPER BLADE (FOR GENERAL USE)
• Common Device Name: RAZOR, SURGICAL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 14427922
• Report Number: 1423507-2022-00012
• Device Sequence Number: 15069233
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4406
• Device Catalogue Number: 4406
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown