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

Model Number	7539LF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem 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.
Additional 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
• 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: 18525378
• Report Number: 1282497-2024-00002
• Device Sequence Number: 7728060
• Product Code: KGX
• UDI-Device Identifier: 10884527021925
• UDI-Public: 10884527021925
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/07/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown