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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M MICROPORE PAPER TAPE; MICROPORE¿ PAPER TAPE
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3M HEALTH CARE 3M MICROPORE PAPER TAPE; MICROPORE¿ PAPER TAPE Back to Search Results
Model Number N/A
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Local Reaction (2035)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
End of report.
 
Event or Problem Description
A plastic surgeon reported two patients experienced severe reactive dermatitis.The dermatitis allegedly occurred exclusively where 1530-1 3m¿ micropore¿ tape was applied.The plastic surgeon reported there was no sign of infection, clearly a reactive dermatitis, thus antibiotics had no effect.The micropore¿ tape was discontinued.The plastic surgeon reported the dermatitis slowly resolved following input from dermatologists and use of topical steroid creams (unspecified type).
 
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Brand Name
3M MICROPORE PAPER TAPE
Common Device Name
MICROPORE¿ PAPER TAPE
Manufacturer (Section D)
3M HEALTH CARE
2510 conway ave
st. paul MN 55144
MDR Report Key8301950
Report Number2110898-2019-00021
Device Sequence Number10780770
Product Code KGX
UDI-Device Identifier30707387065974
UDI-Public30707387065974
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/04/2019
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 Health Professional
Device Model NumberN/A
Device Catalogue Number1530-1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/15/2019
Initial Report FDA Received Date02/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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