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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Purulent Discharge (1812); Skin Tears (2516)
Date of Event	07/12/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The nurse reported the patient's death occurred on or around (b)(6) 2018 and was not related to the application of 3m¿ tegaderm¿ chg dressing.The nurse reported the event occurred approximately 2 weeks ago.On (b)(6) 2018 was used for date of event based on the estimation from the customer.Lot number was not provided.Without a lot number, expiration date and manufacture date could not be determined.Although we are filing a medwatch report for this adverse event, we do not believe the patient death was device related based on facility input and 3m internal medical review.
Event or Problem Description
A nurse reported a very sick post-operative heart patient in icu had a cordis catheter placed in the right internal jugular vein.A 1657 3m¿ tegaderm¿ chg dressing was reportedly applied to the site.After 3-4 days of application, the dressing was removed and discarded.The patient experienced skin removal and pus was allegedly found at the insertion site when the product was removed.The area was cleansed, the cordis catheter was removed and bacitracin ointment was applied to the site.The patient's wbc was elevated so his arterial line was also reportedly removed.The arterial line also had a tegaderm¿ chg dressing applied to the site and no issue occurred at the arterial site.The right ij site was healing and the wbc counts were down when the patient was discharged from icu.The very sick patient reportedly expired on or around (b)(6) 2018 not related to his cordis site issue.The cause of death was listed as heart failure.The nurse reported this was a very sick patient and the death was "definitely not related to application of the tegaderm¿ chg dressing".

• Brand Name: 3M TEGADERM CHG DRESSING
• Common Device Name: TEGADERM CHG DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 7785866
• Report Number: 2110898-2018-00083
• Device Sequence Number: 228065
• Product Code: FRO
• UDI-Device Identifier: 30707387578313
• UDI-Public: 30707387578313
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K080620
• 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): 08/15/2018

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): Initial
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/15/2018
• 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: Death
• Patient Age: 77 YR