MAUDE Adverse Event Report: CARDINAL HEALTH 2X3 3/4 TELFA ISLAND DRESSING; TAPE AND BANDAGE, ADHESIVE

Model Number 7539LF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that on january 03, 2024, a home patient (hp) called them to report that they had a severe rash from the telfa island dressing.The patient had to take antibiotics.

Manufacturer Narrative

A device history record (dhr) review could not be performed because the lot number is unknown.No samples or photos were provided for review.The complaint could not be confirmed, and a root cause could not be determined.No new actions will be taken.If additional information is received, this complaint will be reopened.This complaint will be used for tracking and trending purposes.

• Brand Name: 2X3 3/4 TELFA ISLAND DRESSING
• Type of Device: 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: 18525378
• MDR Text Key: 333028512
• Report Number: 1282497-2024-00002
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 10884527021925
• UDI-Public: 10884527021925
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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: 7539LF
• Device Catalogue Number: 7539LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 02/07/2024
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other