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); Scarring (2061)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter occupation not provided.Product lot # was not provided.Product lot # was not provided, therefore device manufacture date is unknown.The sample was returned for evaluation.There was not enough sample returned to be tested.The sample was visually inspected and did not appear to be defective.3m will continue to monitor.End of report.
Event or Problem Description
A male patient alleged redness/scarring after he applied and removed 3m¿ micropore¿ surgical tape (1530-1) to his face to secure a plastic eye patch over the right eye after cataract surgery on (b)(6) 2019.The patient applied the tape he received from the hospital that same evening to the forehead and side of the face to secure the eye patch.The eye patch was worn overnight and the skin redness was noticed under the tape application site after he removed the tape the next day.The tape was not reapplied.The patient purchased an otc scar cream and applied the cream one time to the red skin areas with no improvement observed.The patient visited his eye surgeon the day after surgery for follow up and no medical treatment was provided for the symptom.The patient visited his eye surgeon again 2.5 weeks later and was prescribed hydrocortisone valerate cream to apply twice a day.The patient reported that the skin area, described as redness with scarring, has lightened.

• 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: 9380083
• Report Number: 2110898-2019-00141
• Device Sequence Number: 2258055
• Product Code: KGX
• UDI-Device Identifier: 30707387065974
• UDI-Public: 30707387065974
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1530-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/26/2019
• 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: Other
• Patient Age: 74 YR