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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Rash (2033); Scarring (2061)

Event Date 10/09/2019

Event Type  Injury  

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 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
• Type of Device: MICROPORE¿ PAPER TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH, WERK; manufacturing medical devices; edisonstrasse 6; kamen, 59174 ; GM 59174
• Manufacturer Contact: dianne gibbs ; 3m center building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 9252170
• MDR Text Key: 164174280
• Report Number: 2110898-2019-00126
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 30707387065974
• UDI-Public: 30707387065974
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1530-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 12 YR
• Patient Weight: 45