MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; GAUZE,BORDER,4"X4",2.5"X2.5"PAD,STERILE

Catalog Number MSC3244H

Device Problem Biocompatibility (2886)

Patient Problems Burn(s) (1757); Local Reaction (2035)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that end-user developed allergic reaction and chemical burn from the adhesive of the bordered gauze adhesive island wound dressing requiring oral antibiotic and topical corticosteroid for treatment.The end-user reported that she developed itchiness after 24 hours of application and when she took the dressing off, she noted redness that followed the shape of the bordered gauze/adhesive.Per report, the dressing was applied while end- user was in the doctor's office for a follow-up on the laceration that she sustained to her right lower leg.It was reported that after an unknown number days of using steri-strips and collagen dressing, the clinic applied the bordered gauze adhesive island wound dressing to the end-user's right lower leg.This was the first time that the end-user used this dressing and she is reportedly allergic to sulfa, penicillin, and iv contrast dye.The end-user stated that she took oral clindamycin for 10 days and applied triamcinolone ointment to the wound.Per report, the wound is now well-healing and is being covered by gauze and elastic net.Due to the reported need for medical intervention, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that end-user developed allergic reaction and chemical burn from the adhesive of the bordered gauze adhesive island wound dressing requiring oral antibiotic and topical corticosteroid for treatment.

• Type of Device: GAUZE,BORDER,4"X4",2.5"X2.5"PAD,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 7930029
• MDR Text Key: 122500795
• Report Number: 1417592-2018-00109
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/03/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MSC3244H
• Device Lot Number: 75717110008
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 113