MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ MICROPORE¿ PAPER TAPE; TAPE AND BANDAGE, ADHESIVE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Peeling (1999); Skin Irritation (2076); Patient Problem/Medical Problem (2688)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: 3M¿ MICROPORE¿ PAPER TAPE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul, mn
• MDR Report Key: 9829558
• Report Number: 2110898-2020-00008
• Device Sequence Number: 2896138
• Product Code: KGX
• UDI-Device Identifier: 30707387065974
• UDI-Public: 30707387065974
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 1530-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other