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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW TEGADERM¿ IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW

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3M HEALTH CARE 3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW TEGADERM¿ IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Extravasation (1842)
Event Date 07/01/2018
Event Type  Injury  
Manufacturer Narrative
Lot number was not provided. Without a lot number, expiration date and manufacture date could not be determined. End of report.
 
Event Description
A nurse reported a patient from the er had their implanted port accessed with a huber needle for a power injection of ct contrast dye during a diagnostic test. A biopatch was reportedly placed under the huber needle and a 1668 tegaderm¿ iv transparent film dressing with adhesive-free window was applied to the site. The nurse reported the huber needle migrated out of the implanted port but remained under the skin. The patient reportedly experienced an extravasation of ct contrast dye in the skin around the port site. The dressing remained fully intact. The port was de-accessed and the patient was treated with multiple subcutaneous injections of hyaluronidase.
 
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Brand Name3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW
Type of DeviceTEGADERM¿ IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW
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
3m center building 275-5w-06
2510 conway ave
st. paul, MN 55144
6517379117
MDR Report Key7679259
MDR Text Key113738413
Report Number2110898-2018-00075
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number1668
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/11/2018 Patient Sequence Number: 1
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