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	Abrasion (1689)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Material no.: 4406.Batch no.: unknown.It was reported a large area of redness, irritation, and abrasions on the patient's abdomen.Per email: i'm reaching out to report a product complaint/incident that happened at surgery.Pease see the below information for details.I'm working to get a photo of the patient from the customer.I've already had a follow up meeting and performed additional education with the customer.Item # 5513e and 4406.Date of incident: (b)(6) 2021.A large area of redness, irritation, and abrasions on the patient's abdomen omitted.Follow up information received on 3/3/2021, stated the following, making this a reportable event.I do not have the specific lot #.The customer has a photo of the affected patient area, but they are waiting for their quality team to determine if they are allowed to send it to me.The case was canceled due to the significant irritation of the skin.

• 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: 11600616
• Report Number: 1423507-2021-00019
• Device Sequence Number: 3460105
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4406
• Device Catalogue Number: 4406
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/31/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other