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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM TRANSPARENT FILM DRESSING

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3M HEALTH CARE 3M TEGADERM TRANSPARENT FILM DRESSING Back to Search Results
Catalog Number 1624W
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Burning Sensation (2146)
Event Date 08/31/2017
Event Type  Injury  
Manufacturer Narrative
Customer did not have lot number or sample for this event.
 
Event Description
A (b)(6) y/o female customer reported she experienced redness, itching, burning and a rash from her wrist to her upper arm when a 1624w tegaderm dressing was applied to secure a peripheral catheter. The reaction started as redness and itching and within seven days spread to the entire length of her left inner arm. She was seen in the er and was given iv benadryl for treatment. She was also given a rx for keflex and instructed to take otc oral benadryl. The reaction was reportedly improving.
 
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Brand Name3M TEGADERM TRANSPARENT FILM DRESSING
Type of DeviceTEGADERM TRANSPARENT FILM DRESSING
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
275 5w-06
st. paul, MN 55144
6517333091
MDR Report Key6873788
MDR Text Key86554495
Report Number2110898-2017-00119
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 consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 09/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1624W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/11/2017
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: 09/18/2017 Patient Sequence Number: 1
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