MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ TEGADERM¿; 3M¿ TEGADERM¿ HP TRANSPARENT FILM DRESSING, 9534HP

Model Number	9534HP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Blister (4537); Swelling/ Edema (4577)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported to 3m a pediatric patient developed slight redness, swelling and a small number of blisters around the puncture site of the indwelling needle after use of 3m¿ tegaderm¿ dressing 9534hp for iv securement.The four years and seven months old male patient was admitted to the hospital for coughing for five days.The symptoms started after three days of wear.The skin was disinfected with iodine.The following day the mother of the patient reported bringing her child to the hospital and found the skin around the puncture site of the indwelling needle had large redness, swelling and many blisters.A dermatologist was consult and a wet compress with saline was applied to the site.Hydrocortisone butyrate cream and mupirocin ointment was prescribed for two topical applications daily and the symptoms started to improve.
Additional Manufacturer Narrative
H10: device has not been returned; therefore, 3m is unable to analyze the complaint due to not enough information.The reported skin symptoms can be due to skin sensitivities to adhesive products and/or attributed to improper application or removal of the product.There is a percentage of the population who are sensitive or who may become sensitive to adhesive products.Refer to product packaging and instructions for use for proper application and removal technique.Prepare the site according to the facility's protocol.Allow all preps and protectants to dry completely before applying dressing.Application: do not stretch the dressing as tension can cause skin trauma.Removal: gently grasp an edge and slowly peel the dressing from the skin in the direction of hair growth.Avoid skin trauma by peeling the dressing back, rather than pulling it up from the skin.3m will continue to monitor.

• Brand Name: 3M¿ TEGADERM¿
• Common Device Name: 3M¿ TEGADERM¿ HP TRANSPARENT FILM DRESSING, 9534HP
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: nadia battah ; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 17595643
• Report Number: 2110898-2023-00079
• Device Sequence Number: 7364845
• Product Code: NAD
• UDI-Device Identifier: 30707387807550
• UDI-Public: 30707387807550
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2023

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: Health Professional
• Device Expiration Date: 04/15/2026
• Device Model Number: 9534HP
• Device Lot Number: 33HP7W8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male