MAUDE Adverse Event Report: COVIDIEN STD POROUS CLOTH TAN TAPE 1X10YDNS; TAPE AND BANDAGE, ADHESIVE

Model Number 5806C

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

The incident sample has 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.

Event Description

The customer reported that the product is not easy to tear and it's very sticky and sticking to patient's hair.This issue occurred within a veterinary setting.

• Brand Name: STD POROUS CLOTH TAN TAPE 1X10YDNS
• 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: 12079785
• MDR Text Key: 258970341
• Report Number: 1282497-2021-10473
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 10884521138865
• UDI-Public: 10884521138865
• 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: 06/28/2021

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: 5806C
• Device Catalogue Number: 5806C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1