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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); Unspecified Infection (1930); Rash (2033); Skin Irritation (2076)
Event Date 07/29/2019
Event Type  Injury  
Manufacturer Narrative
Gender information was provided for 3 out of 6 patients. Date of event: exact date of reported events was not provided. The events were reported on (b)(6) 2019 and this date was used for the date of the events. Initial reporter's occupation not provided. The cause of the reported skin reactions/infection could not be determined. The customer did not provide a sample(s) to 3m for analysis. Specific information was only provided for 3 out the 6 pts who reportedly experienced an adverse event. Further information was requested by 3m, however not provided. Manufacturing batch records were reviewed and found no manufacturing issues or process anomalies found that could relate to this issue. Retain product samples were inspected and did not contain any open seals.
 
Event Description
A hematology blood transfusion hospital in (b)(6) reported six pediatric patients (all ages and genders not provided) with a port-a-cath allegedly experienced skin irritation and possible infection. The hospital reported 1626w 3m¿ tegaderm¿ dressings were applied to protect the port-a-cath on each patient. Clabsi was alleged for two of the children, where a physician replaced the ports. No further details were provided on these two incidents. Open packaging of the tegaderm dressing was also reported. The hospital provided specific details on three patient incidents; a male pediatric patient developed skin redness after application of the referenced dressings to protect a port-a-cath. The alleged skin redness was reportedly 2cm x 2cm in size and occurred inside the dressing area on the chest. The skin redness appeared after 3-4 days of wear of the most recently applied dressing and resolved in one week. A second male pediatric patient developed a skin rash with itching after application of the referenced dressings to protect a port-a-cath. The alleged rash was reportedly 2cm x 2cm in size and occurred inside the dressing area on the upper chest. The rash appeared after 3-4 days of wear of the most recently applied dressing and resolved in one week. A third male pediatric patient developed blisters after application of the referenced dressings to protect a port-a-cath. The alleged blisters were reportedly within a 2cm x 2cm area and occurred inside the dressing area on the upper chest. The blisters appeared after 3-4 days of wear of the most recently applied dressing and resolved in one week. In all three cases the dressings were applied in contact with an open wound. Alcohol was used to prep the skin prior to application. The dressings were applied over a two-week period and were changed once per week. The patients had no known history of skin pathologies, sensitivities or allergies. The patients were changed to a new catheter. No further medical treatment was required.
 
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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 Key8941503
MDR Text Key155931826
Report Number2110898-2019-00097
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/09/2020
Device Model NumberN/A
Device Catalogue Number1626W
Device Lot Number2020-12 TJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2017
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: 08/28/2019 Patient Sequence Number: 1
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