MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I.V. SECUREMENT DRESSING; TEGADERM CHG DRESSING

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Necrosis (1971)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information was not provided.Date of event: reporter stated the event occurred in (b)(6) 2019.Specific date was not provided.Lot number was not provided.Expiration date and manufacture date cannot be determined without a lot number.The nurse reported the patient had a diagnosis of toxic epidermal necrolysis.The patient reportedly had 16 dressing changes at the catheter insertion site; only one 3m¿ tegaderm¿ chg dressing had been applied to the site for a period of approximately 16 hours.Biopatch was reportedly applied to the site prior to application of the tegaderm¿ chg dressing.The patient's skin was reportedly not healthy or intact prior to application of the tegaderm¿ chg dressing.The nurse reported the patient's skin was not healthy or intact prior to application of the tegaderm chg dressing.3m¿ tegaderm¿ chg dressing instructions for use states the product should be applied to clean, dry skin.The dressing should be large enough to provide at least one-inch margin of adherence on dry, healthy skin around the catheter site.3m technical service specialist contacted the nurse for discussion and product education.End of report.
Event or Problem Description
A nurse reported an inpatient with toxic epidermal necrolysis had a left internal jugular (ij) catheter in place due to limited venous access.The nurse reported one 1657 3m¿ tegaderm chg dressing was applied to the site.The skin around the insertion site was "not healthy or intact" prior to application of the tegaderm chg dressing.The nurse reported biopatch had been applied to the site prior to application of the tegaderm chg dressing.The nurse reported the patient experienced skin necrosis around the catheter insertion site and the patient will require skin grafting.

• Brand Name: 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I.V. SECUREMENT DRESSING
• Common Device Name: TEGADERM CHG DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8316954
• Report Number: 2110898-2019-00025
• Device Sequence Number: 16390193
• Product Code: FRO
• UDI-Device Identifier: 30707387578313
• UDI-Public: 30707387578313
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K171908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/07/2019
• 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; Required Intervention
• Patient Age: 23 YR