MAUDE Adverse Event Report: COVIDIEN CLOTH TAPE 6 IN X 10 YD; TAPE AND BANDAGE, ADHESIVE

Model Number	9416C
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample and additional information has been requested but to date has not been received.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported they have had multiple reports of 9416c tearing skin.

• Brand Name: CLOTH TAPE 6 IN X 10 YD
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12211165
• Report Number: 1282497-2021-10506
• Device Sequence Number: 4542403
• Product Code: KGX
• UDI-Device Identifier: 10884521084421
• UDI-Public: 10884521084421
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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: No Information
• Device Model Number: 9416C
• Device Catalogue Number: 9416C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/22/2021
• Patient Sequence Number: 1