MAUDE Adverse Event Report: COVIDIEN STD POROUS CLOTH TAPE 1X10YD NS; TAPE AND BANDAGE, ADHESIVE

Model Number 2531C

Device Problem Separation Problem (4043)

Patient Problem Skin Tears (2516)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

Requests for additional information have been attempted with no response from the reporter.The incident sample has also been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the tape is pulling the skin off when being removed from the animal when used in a veterinary setting.

• Brand Name: STD POROUS CLOTH TAPE 1X10YD NS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): CM AMERICAS; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11936050
• MDR Text Key: 255110843
• Report Number: 1282497-2021-10238
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 10884521138797
• UDI-Public: 10884521138797
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2021

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
• Device Operator: No Information
• Device Model Number: 2531C
• Device Catalogue Number: 2531C
• Device Lot Number: 525301X
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/03/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1