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U.S. Department of Health and Human Services

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

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3M HEALTH CARE 3M TEGADERM DRESSING TEGADERM¿ DRESSING Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Rash (2033); Swelling (2091)
Event Date 09/19/2017
Event Type  Injury  
Manufacturer Narrative
A lot number was not provided. Without a lot number, expiration date, manufacture date and udi could not be determined. There was neither a lot number or product sample available for analysis. In general, it can be stated for tegaderm 1624w dressings, that multiple studies have been conducted that have demonstrated appropriate dressing bio-compatibility and safety performance criteria, when the device is used appropriately on humans. Examples of such studies may include, but are not limited to, cytotoxicity testing, primary skin irritation, human cumulative irritation patch test (hcipt), human repeat insult patch test (hript), intracutaneous irritation, and systemic toxicity. In addition to performing these studies, 3m monitors its medical devices with manufacturing controls such as residual solvent release specifications and testing, adhesive basis weight controls, retain samples, and functional release specifications and testing. Despite these studies and controls, there is a percentage of the population who are sensitive or who may become sensitive to adhesive products. To monitor these situations, medical complaints are trended to allow for appropriate corrective action to be taken if the trend deviates from historical values. End of report.
 
Event Description
A hospital employee in (b)(6) reported a patient experienced skin dermatitis described as erythema, skin swelling and rashes when 1624w tegaderm dressings were used to secure an insulin sensor. An unspecified type of topical steroid cream was reportedly used for treatment.
 
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Brand Name3M TEGADERM DRESSING
Type of DeviceTEGADERM¿ 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
dianne gibbs
275 5w-06
st. paul, MN 55144
6517379117
MDR Report Key8219251
MDR Text Key132202873
Report Number2110898-2019-00005
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number1624W
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 Received09/20/2017
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: 01/04/2019 Patient Sequence Number: 1
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