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	Rash (2033)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
Material no.: 4406.Batch no.: 0321.It was reported by the sales representative that the patient experienced a rash allergic reaction prior to surgery.Customer was in pre-op prepping the patient for surgery.When customer started to use our general blade clippers the patient start to break out in a rash.Customer said the patient did seem to have sensitive skin and possible allergy.It got worse in the or so they had to treat reaction prior to surgery.
Additional Manufacturer Narrative
The supplier of this product (panasonic) was made aware of this reported issue of reaction.A photo was provided for evaluation.Unfortunately, only the product box was photographed.As a result, bd was unable to verify the reported issue and determine a definitive root cause at this time.If samples, additional photos or information become available, bd will re-open and investigate accordingly.A device history review was completed by panasonic and the inspection passed.No further actions are required.This failure will continue to be tracked and trended.
Event or Problem Description
It was reported by the sales representative that the patient experienced a rash allergic reaction prior to surgery.Customer was in pre-op prepping the patient for surgery.When customer started to use our general blade clippers the patient start to break out in a rash.Customer said the patient did seem to have sensitive skin and possible allergy.It got worse in the or so they had to treat reaction 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
• MDR Report Key: 12385689
• Report Number: 1423507-2021-00042
• Device Sequence Number: 17301719
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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 Expiration Date: 03/01/2026
• Device Model Number: 4406
• Device Catalogue Number: 4406
• Device Lot Number: 0321
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other