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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033); Scarring (2061)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact date of event not provided.Exact product used was not confirmed.Product catalog & lot #'s were not provided.Product lot # was not provided, therefore device manufacture date is unknown.The reporter indicated 3m¿ micropore¿ surgical tape was probably associated with this reported incident.Exact product used was not confirmed.No sample was available for evaluation.No photos were provided to 3m for evaluation.End of report.
Event or Problem Description
A complaint received from the danish medicines agency alleged a skin rash, skin redness and a 2x2 cm scar on the left cheek of a premature pediatric patient.The patient reportedly had a feeding tube affixed with a white bandage and after ten days, a rash appeared on the left cheek where the bandage was.The white bandage used was alleged to probably be 3m¿ micropore¿ surgical tape.Cosmetic skin change was alleged to still be visible twelve years later.

• 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 Key: 9252170
• Report Number: 2110898-2019-00126
• Device Sequence Number: 1724644
• Product Code: KGX
• UDI-Device Identifier: 30707387065974
• UDI-Public: 30707387065974
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• 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: 10/09/2019
• Initial Report FDA Received Date: 10/29/2019
• 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: Death; Other
• Patient Age: 12 YR
• Patient Weight: 45