MAUDE Adverse Event Report: COVIDIEN WATERPROOF TAPE 1 X 10YD; TAPE AND BANDAGE, ADHESIVE

Model Number	3142C
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Tears (2516)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the tape was ripping the skin off.Additional information was received from the customer stated that the tape was used on a cat.There was some skin irritation observed with no signs of infection.The customer further stated that an otc topical ointment was used as a treatment.
Additional Manufacturer Narrative
Investigation summary: the device history record indicated that the product was released accomplishing all quality standards.There were no samples returned for evaluation by the customer therefore the supplier completed the investigation on retained samples from the reported lot number.The retained samples were tested on the lower end of the specification.Adhesion 1min peel of 9.7,10,12.5,10.0,10.7,10.0,10.2,9.5 was tested on the 8 retains.The specification is 9-20 n/25mm.The results of the testing indicate the retained product did not exhibit high adhesion values which would rip off skin.Furthermore, there has been no change to the calendaring and slitting adhesion specification.Based on the available information, the root cause was not identified as the investigation on retained samples shows that the product was manufactured within specification.The supplier will continue to monitor the adhesion value as well as testing protocol and production test plan of the tape to ensure that it does not go out of the specification.This complaint will be used for tracking and trending purposes.

• Brand Name: WATERPROOF TAPE 1 X 10YD
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11448440
• Report Number: 1282497-2021-09958
• Device Sequence Number: 3359954
• Product Code: KGX
• UDI-Device Identifier: 10884521138827
• UDI-Public: 10884521138827
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 3142C
• Device Catalogue Number: 3142C
• Device Lot Number: 494926X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/20/2021
• Patient Sequence Number: 1