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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES, INC. GAUZE,BORDER,4"X4",2.5"X2.5"PAD,STERILE Back to Search Results
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.
 
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Type of DeviceGAUZE,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 Key7930029
MDR Text Key122500795
Report Number1417592-2018-00109
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received10/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMSC3244H
Device Lot Number75717110008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
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 Treatment Data
Date Received: 10/03/2018 Patient Sequence Number: 1
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