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U.S. Department of Health and Human Services

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

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3M HEALTH CARE NEXCARE TEGADERM WATERPROOF TRANSPARENT 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); Burning Sensation (2146)
Event Date 01/13/2020
Event Type  Injury  
Manufacturer Narrative
Information was not provided. Lot 19206j was packed out july 25, 2019 for 3m ¿ consumer health care division and labeled on the primary packaging. 3m ¿ medical solutions division manufactures the individual dressings and the pouches are printed with date of manufacture and expiration. No sample has been received for analysis. The 2-year complaint history was reviewed for the product's global sales code (gsc) of szn and reported failure. No trends were observed. 3m will continue to monitor. Testing confirms the biocompatibility of nexcare¿ tegaderm¿ transparent dressings for their intended use. In addition to performing clinical studies, 3m monitors its medical devices with manufacturing controls including in-process and release specifications/testing. Despite these studies and controls, there is a percentage of the population who are sensitive or who may become sensitive to adhesive products.
 
Event Description
A female consumer applied the referenced dressing over a cut/abrasion located on her right arm, between the elbow and shoulder. The dressing was applied on (b)(6) 2020. Prior to application, the wound was washed with dial® soap, then allowed to dry. No ointments/creams were applied on the wound. The consumer alleged after one hour of wear, she experienced a burning sensation from the skin area. She alleged her skin around the outside edge of dressing was red. The consumer reported she had an allergy to an unspecified antibiotic. No other known allergies/skin sensitivities were specified. The dressing was removed. The skin underneath the dressing was reportedly not affected. The burning sensation resolved after approximately 1 hour. The consumer applied another dressing the next day. The same skin prep was conducted. No ointments/creams were applied on the wound/skin area. The consumer alleged after one hour of wear, she experienced a burning sensation from the skin area. The dressing was removed 2-3 hours after symptom onset. The burning sensation resolved after a few hours. The consumer reported the skin area was a bit red, however improved after 2 days. On (b)(6) 2020, the consumer reported the skin area was bubbly and felt tight. The consumer applied a&d ointment. The bubbly appearance of the skin resolved by the next day. The consumer alleged a bright red mark "like a stamp" was visible on her skin. She continued to wash area and apply a & d ointment. The consumer visited an urgent care on (b)(6) 2020. The doctor reportedly advised that the skin area was slightly infected. The doctor prescribed an antibiotic, generic bactrim, to use twice/day for 10 days. The consumer reported that the redness on her arm was slightly improving.
 
Manufacturer Narrative
The sample and primary carton were returned for evaluation. One intact dressing was returned along with two opened cold seals and a frame/liner. A visual review of the returned material found no damage, defects or foreign matter. The 2-year complaint history was reviewed for the product's global sales code (gsc) of szn and reported failure. No trends were observed. 3m will continue to monitor. Testing confirms the biocompatibility of nexcare¿ tegaderm¿ transparent dressings for their intended use. In addition to performing clinical studies, 3m monitors its medical devices with manufacturing controls including in-process and release specifications/testing. Despite these studies and controls, there is a percentage of the population who are sensitive or who may become sensitive to adhesive products.
 
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Brand NameNEXCARE TEGADERM WATERPROOF TRANSPARENT 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
bryan becker
2510 conway avenue
st. paul, MN 55144
6517375578
MDR Report Key9632961
MDR Text Key176546048
Report Number2110898-2020-00004
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,Followup
Report Date 02/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberN/A
Device Catalogue NumberH1624
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2020
Was Device Evaluated by Manufacturer? Yes
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: 01/27/2020 Patient Sequence Number: 1
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