MAUDE Adverse Event Report: COVIDIEN 61301 STER GZE PADS 100'S 2X2; GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE

Model Number	61301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported that the spouse of a home patient contacted baxter by phone and reported that the patient got an infection on tube site and the swabsticks (baxter product code ek4061, lot # unknown, (b)(4)) were making it irritated and inflamed.The skin got super red and it burned and hurt every time they applied it.They got a set of iodine swabs from the clinic that they are using for now and it does not irritate the wound.The patient also used gauze, 2x2 sterile (product code ek7417, lot # unknown).
Additional Manufacturer Narrative
Section e1 has been updated to include the name and address of the distributor who reported this event.

• Brand Name: 61301 STER GZE PADS 100'S 2X2
• Common Device Name: GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 10360007
• Report Number: 1018120-2020-00419
• Device Sequence Number: 3462983
• Product Code: NAB
• UDI-Device Identifier: 30884521083947
• UDI-Public: 30884521083947
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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
• Operator of Device: No Information
• Device Model Number: 61301
• Device Catalogue Number: 61301
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other