MAUDE Adverse Event Report: CARDINAL HEALTH STD POROUS CLOTH TAPE 1INX10YD NS; TAPE AND BANDAGE, ADHESIVE

Model Number	2531C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they have had a staff member experience anaphylaxis reaction.The customer wanted to inquire if the item contained latex because the brochure shows it in fact contains latex yet the picture on the site says hypoallergenic.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.There were no samples received for the investigation but per product specifications, the product does contain latex.Every carton of product does clearly indicate latex content.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: STD POROUS CLOTH TAPE 1INX10YD NS
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15121245
• Report Number: 1282497-2022-10707
• Device Sequence Number: 5601594
• Product Code: KGX
• UDI-Device Identifier: 10884521138797
• UDI-Public: 10884521138797
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 2531C
• Device Catalogue Number: 2531C
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown