3M? MICROPORE? PAPER TAPE N/A 1530-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-13 for 3M? MICROPORE? PAPER TAPE N/A 1530-1 manufactured by 3m Health Care.

Event Text Entries

[183374079] Reporter occupation not provided. Reported from children's burn unit. No lot number, questionnaire or picture was available. Three attempts have been made to contact customer for additional information. To date, no additional information has been received. It was described that a blister developed presumably in the application area of micropore. Probably upon removal; skin loss was observed. The depth of the wound is unknown; however, skin grafting was alleged to treat the injury. Usually if skin tears appear, only the dermis, sometimes also parts or the complete dermis may be removed. These cases are quite rare and if they appear, they are typically in elderly populations with fragile and atrophic skin may be affected. End of report.
Patient Sequence No: 1, Text Type: N, H10


[183374080] An eu regulatory authority in (b)(6) reported a customer alleged on (b)(6) 2019 they applied 3m? Micropore? Tape 1530-1 on their child at home. Patient specifics are not available. Location where the tape was applied, the length of time it was on the child and indication was not provided. Symptoms alleged included blistering and full thickness wounds. Unknown if there was difficulty removing the tape. Reporter alleged patient required medical intervention that included debridement and skin graft. Current status of patient was reported as "continuing". History of allergies and skin sensitivities are unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2110898-2020-00008
MDR Report Key9829558
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-13
Date of Report2020-03-13
Date of Event2019-07-16
Date Mfgr Received2019-08-13
Date Added to Maude2020-03-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDIANNE GIBBS
Manufacturer Street3M CENTER BUILDING 275-5W-06
Manufacturer CityST. PAUL, MN
Manufacturer CountryUS
Manufacturer Phone7379117
Manufacturer G13M DEUTSCHLAND GMBH, WERK
Manufacturer StreetMANUFACTURING MEDICAL DEVICES EDISONSTRASSE 6
Manufacturer CityKAMEN, 59174
Manufacturer CountryGM
Manufacturer Postal Code59174
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3M? MICROPORE? PAPER TAPE
Generic NameTAPE AND BANDAGE, ADHESIVE
Product CodeKGX
Date Received2020-03-13
Model NumberN/A
Catalog Number1530-1
Lot NumberUNK
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer Address2510 CONWAY AVE ST. PAUL, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-13

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