MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ TEGADERM¿; 3M¿ TEGADERM¿ CHG DRESSING

Model Number	1657
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier and race: unknown.No sample received for analysis.A two year review of complaints for the reported alleged injury for this product was reviewed and no trends were observed.3m will continue to monitor.
Event or Problem Description
A hospital reported an incident involving a 62-year-old male patient.On (b)(6) 2022, the tegaderm chg dressing was used to secure the patient's picc (peripherally inserted central catheter) line located on his brachial (date of picc line insertion was not reported).The area was cleansed with chloroprep and the picc line was stabilized with stat-lock before the dressing was placed.No skin protectant was applied on the area before the dressing was placed.The patient received iv fluids and other unspecified therapies through the picc line.On (b)(6) 2022, during an outpatient visit for treatment and picc line dressing change, the dressing was noted with yellow drainage and the area where the chloroprep was applied felt like pitting edema.After the dressing was removed, the patient's skin was moist, with yellow patches and granulation.The area was treated with topical antibiotic and steroid (clotrimazole/bacitracin/neomycin).The alleged injury resolved after one month and the area is scarred.The patient had no pre-existing skin conditions and the dressing was applied on intact skin.No allergies, medical history or intervention reported.

• Brand Name: 3M¿ TEGADERM¿
• Common Device Name: 3M¿ TEGADERM¿ CHG DRESSING
• 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: dianne gibbs ; 275 5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15882557
• Report Number: 2110898-2022-00119
• Device Sequence Number: 14896818
• Product Code: FRO
• UDI-Device Identifier: 30707387578313
• UDI-Public: 30707387578313
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2022

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: 06/04/2024
• Device Model Number: 1657
• Device Catalogue Number: 1657
• Device Lot Number: 33KPA3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Hispanic