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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

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3M HEALTH CARE 3M TEGADERM IV TRANSPARENT FILM DRESSING WITH ADHESIVE-FREE WINDOW Back to Search Results
Catalog Number 1668
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Skin Erosion (2075)
Event Date 05/23/2017
Event Type  Injury  
Event Description
Customer reported an outpatient with metastatic colon cancer had an implanted port located in her chest. The implanted port was accessed for an iv treatment of 5fu (chemotherapy). Cavilon no sting barrier film was reportedly applied to the site and then covered with a tegaderm iv transparent film dressing with adhesive free window. The patient went home and the infusion was scheduled to run for 46 hours. When the infusion finished, the outpatient removed the dressing and de-accessed the site. Two days after removal of the dressing, the patient reportedly experienced redness and blistering under the entire area where the tegaderm iv transparent film dressing and barrier film had been applied. The patient's therapy was reportedly held due to her skin condition and she was treated with oral antibiotics and an otc topical steroid cream.
 
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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
karen krenik, bsn
3m center building 275-5w-06
2510 conway ave
st. paul, MN 55144
6517333091
MDR Report Key6669828
MDR Text Key78475217
Report Number2110898-2017-00090
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 06/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/05/2017
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: 06/27/2017 Patient Sequence Number: 1
Treatment
CENTRAL LINE PORT CATHETER; CHEMOTHERAPY INFUSION 5FU
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