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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND-AID HYDRO-SEAL UNSPECIFIED DRESSING, WOUND, OCCLUSIVE

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JOHNSON & JOHNSON CONSUMER INC BAND-AID HYDRO-SEAL UNSPECIFIED DRESSING, WOUND, OCCLUSIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Scarring (2061)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. This report is for one (1) band-aid unspecified can (unspecified band-aid brand hydroseal bandage). Lot # and udi # are not available. Device is not distributed in the united states but is similar to device marketed in the usa (band-aid hydroseal unspecified usa). Device is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states but is similar to device marketed in the usa (band-aid hydroseal unspecified usa). Device evaluation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
A female consumer reported an event using band-aid brand hydroseal bandage. On an unspecified day, the consumer used a band-aid brand hydroseal bandage to avoid a scar forming from a small scrape on her shin. Prior to use, she disinfected the wound and the area. After applying the bandage, the white bump formed as expected. However, when the bump started to feel a little painful, the consumer decided to remove the bandage and inspect the wound. The consumer stated the wound looked possibly infected and she was sure it would leave a big scar. As the pain at the site increased, the wound looked even more infected and the consumer started to worry about osteomyelitis. She consulted a doctor, who diagnosed her with infection/cellulitis, and prescribed an unspecified antibiotic. On (b)(6) 2020 and (b)(6) 2020, the consumer said she had ¿a huge scar on her leg¿ and would require consultations, treatments as well as the use of ¿scar away¿ products. No additional details were provided.
 
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Brand NameBAND-AID HYDRO-SEAL UNSPECIFIED
Type of DeviceDRESSING, WOUND, OCCLUSIVE
Manufacturer (Section D)
JOHNSON & JOHNSON CONSUMER INC
199 grandview rd
skillman NJ 08558 -941
CA 08558-9418
Manufacturer (Section G)
COLOPLAST A/S
holtedam 1
hovedsaden DK-30 50
DA DK-3050
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key9867967
MDR Text Key196479520
Report Number2214133-2020-00011
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/26/2020
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/23/2020 Patient Sequence Number: 1
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