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

Model Number	1660R
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Skin Discoloration (2074); Fluid Discharge (2686)
Date of Event	04/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: no sample received for analysis.A quality analysis was completed and there is no indication of a product quality issue resulting in skin irritation or indication of an adverse trend with tegaderm chg dressings related to skin irritation.3m will continue to monitor.The dressing should be changed if the gel pad is saturated, when the dressing becomes loose or soiled, or in cases where there is swelling, visible drainage, or lost visibility.The chg gel pad is not intended to absorb large quantities of blood or drainage.Per the product ifu, instruction for use: do not use tegaderm¿ chg dressing on premature infants or infants younger than 2 months of age.Use of this product on premature infants may result in hypersensitivity reactions or necrosis of the skin.The safety and effectiveness of tegaderm¿ chg dressing has not been evaluated in children under 18 years of age.Do not allow this product to contact ears, eyes, mouth, or mucous membranes.Do not use this product on patients with known hypersensitivity to chlorhexidine gluconate.The use of chlorhexidine has been reported to cause irritations, sensitization, and generalized allergic reactions.If allergic reactions occur, discontinue use immediately, and if severe, contact a physician.Use caution with chlorhexidine gluconate containing preparations.The patient should be observed for the possibility of hypersensitivity reactions.
Event or Problem Description
A hospital reported a 1.5cm x 1.5cm burn-like skin lesion, yellowish white tissue, clear margins, medium serous exudate, and peripheral redness on an 8-month-old female patient after use of 1660r tegaderm chg.Symptoms started after five days of wear on the patient's right jugular vein.The chg pad was slighted saturated upon dressing change and the irritation was found under the chg pad.Upon removing the dressing, the pediatric patient was crying.There were no difficulties removing the dressing.Topical treatment while using polyurethane foam with silver, hydrogel, and portable low power laser therapy.Anesthesia was not required for the four treatments of laser therapy.After 48 hours of the initial treatment, topical hydrogel was followed.The patient was discharged with home care and the skin irritation is healed.

• 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: nadia battah ; 2510 conway avenue; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 17221150
• Report Number: 2110898-2023-00062
• Device Sequence Number: 17695801
• Product Code: FRO
• UDI-Device Identifier: 30707387578313
• UDI-Public: 30707387578313
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123679
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

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: 08/16/2024
• Device Model Number: 1660R
• Device Catalogue Number: 1657
• Device Lot Number: 33LM8P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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: 8 MO
• Patient Sex: Female