MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE FLEXIBLE CLEAR TAPE; TAPE AND BANDAGE, ADHESIVE

Model Number	771-2PK
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Skin Irritation (2076)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt information was not provided.This product has a 5 year shelf life.Information was not provided.No sample was provided to 3m for evaluation.Root cause of reported issue was not established.The 2-year complaint history was reviewed for the product's global sales code (gsc) of szn and reported product lot #20216j.No trends were observed.3m will continue to monitor.
Event or Problem Description
A male customer reported that he applied the referenced tape to secure a catheter to his inner right thigh on (b)(6) 2020.The tape was reportedly worn while laying down and during showers/baths.The customer reported that he initially used different tape brand for securement without any issues.Prior to application the customer showered, then allowed the skin area to dry.The tape was worn for a couple of hours.Exact duration of wear was not specified.The customer alleged that his thigh began to get red, bumpy and itchy during wear.The reaction was reportedly in the shape of the tape adhesive.No known allergies or skin sensitivities were specified.The customer applied the tape for the next two days, while showering, for a couple of hours each wear.The skin area reportedly worsened and became redder during this time frame.Tiny blisters allegedly formed on the skin.The customer visited a doctor on (b)(6) 2020.The doctor reportedly advised the customer the skin reaction was caused by the tape adhesive and prescribed hydrocortisone cream.The customer switched to using paper tape.The affected skin area reportedly improved.

• Brand Name: NEXCARE FLEXIBLE CLEAR TAPE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul, mn
• MDR Report Key: 10264530
• Report Number: 2110898-2020-00030
• Device Sequence Number: 17010134
• Product Code: KGX
• UDI-Device Identifier: 00051131212732
• UDI-Public: 00051131212732
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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 Expiration Date: 05/05/2025
• Device Model Number: 771-2PK
• Device Catalogue Number: 771-2PK
• Device Lot Number: 20126J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/13/2020
• 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: Required Intervention