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

Model Number 9416C

Device Problem Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 Description

The customer reported they have had multiple reports of 9416c tearing skin.

• Brand Name: CLOTH TAPE 6 IN X 10 YD
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12211165
• MDR Text Key: 262919445
• Report Number: 1282497-2021-10506
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 10884521084421
• UDI-Public: 10884521084421
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 9416C
• Device Catalogue Number: 9416C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1