MAUDE Adverse Event Report: 3M HEALTH CARE 3M MICROPORE TAPE; MICROPORE¿ PLUS PAPER TAPE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Irritation (2076)
Date of Event	08/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model, serial, lot # information and expire date was not provided.The device was not returned by the customer to 3m for evaluation.Product lot # was not provided.Without returned sample or product lot #, further investigation could not be conducted.The customer reported existing allergies to many chemicals.The product sds was provided to the customer.The sds provided did not contain any of the reported known allergens.End of report.
Event or Problem Description
A female customer reported she underwent a recent mtp joint fusion surgery.The woman initially applied a waterproof bandage over the wound site.Per the recommendation of a chemist, the woman switched to apply the referenced tape over the site on (b)(6) 2018.The tape was worn for a half day.The woman alleged she began to experience discomfort.The tape was removed.She alleged the skin that came in contact with the tape was red, sore, itchy and "burn-like".The woman reported she used unspecified antihistamines, antiseptic cream and spray for three days to treat the affected area.She reported the initial treatment was ineffective.On (b)(6) 2018, the woman reported the affected area was worsening.She alleged the affected area stung and itched.The woman reported her gp advised she experienced an allergic reaction.The doctor instructed the woman to take an unspecified antihistamine and apply derma cream.The doctor also provided the woman with a prescription for "elacon" cream to use if the derma cream was ineffective.She alleged experiencing discomfort due to her foot swelling from the recent surgery combined with the allergic reaction.The woman reported allergies to many chemicals including; cetyl stearyl alcohol 20%, dmdm hydantoin, methyldibromo glutaronitrile/phenoxyethanol (mdbgn), and "balsom" of peru.She reported her allergist advised her to always check ingredients on products, place a small amount on the inside of her wrist and wait 24 hours to see if a reaction occurs.The woman reported she did not perform this check prior to applying tape.On (b)(6) 2018, the woman reported her gp gave her an unspecified steroid cream and antihistamine that was used it for 2 weeks.She reported the affected area was improving.

• Brand Name: 3M MICROPORE TAPE
• Common Device Name: MICROPORE¿ PLUS PAPER TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8134819
• Report Number: 2110898-2018-00111
• Device Sequence Number: 11185852
• Product Code: KGX
• UDI-Device Identifier: 30707387005086
• UDI-Public: 30707387005086
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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?: No
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 1530-012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/05/2018
• 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; Required Intervention