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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 Missed Dose (2561)
Event Date 05/30/2018
Event Type  Injury  
Manufacturer Narrative
Lot number was not provided. Without a lot number, expiration date and manufacture date could not be determined. The patient in this report did not experience an injury. An mdr was filed for this report due to missed therapy.
 
Event Description
A nurse reported an outpatient was receiving an iv chemotherapy infusion via an implanted port at home. The port was accessed with a huber needle and the chemotherapy was infusing via an iv pump. A 1668 tegaderm¿ iv transparent film dressing with adhesive-free window was applied to the site. The patient returned the following day and the huber needle was completely de-accessed from the implanted port. The dressing was reportedly still completely intact. The nurse reported this was a very active patient who was working outside when the event occurred. The nurse reported the chemotherapy was discarded and was not re-started or re-dosed. The patient reportedly received his next scheduled chemotherapy infusion two weeks later.
 
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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 Key7655243
MDR Text Key112909182
Report Number2110898-2018-00064
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 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number1668NS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/01/2018
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: 07/02/2018 Patient Sequence Number: 1
Treatment
HUBER NEEDLE
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