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U.S. Department of Health and Human Services

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

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3M HEALTH CARE 3M TEGADERM DRESSING 3M¿ TEGADERM¿ Back to Search Results
Model Number 9543HP
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Blister (4537)
Event Date 03/02/2021
Event Type  Injury  
Manufacturer Narrative
Patient information: unknown. Lot number and expiration date is unknown. Device manufacture date unknown. Device has been discarded; complaint was received without a model number. 3m¿ tegaderm¿ transparent film dressing frame style 9543hp is being used. 3m¿ will continue to monitor.
 
Event Description
A male patient reported undergoing robotic hernia surgery on (b)(6) 2021. Three incisions were made on his abdomen and covered with a 3m¿ tegaderm¿ dressing. The patient removed the dressing 48 hours later and alleged skin redness and blisters in five areas. No medical interventions were required. Currently the patient's skin is healed and reports five areas of scar like symptoms.
 
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Brand Name3M TEGADERM DRESSING
Type of Device3M¿ TEGADERM¿
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
275 5w-06
st. paul, MN 55144
6517379117
MDR Report Key11843331
MDR Text Key251370771
Report Number2110898-2021-00033
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
Type of Report Initial
Report Date 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9543HP
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2021
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: 05/18/2021 Patient Sequence Number: 1
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