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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC RANGE - ADHESIVE BANDAGES DRESSING, WOUND, OCCLUSIVE

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JOHNSON & JOHNSON CONSUMER INC RANGE - ADHESIVE BANDAGES DRESSING, WOUND, OCCLUSIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient information was not provided for reporting. This report is for (range - adhesive bandages ap not applicable 0000rgebabapd 0000rgebabapd). Upc#, and udi # is not available. Device is not distributed in the united states, but is similar to device marketed in the usa (band-aid unspecified usa babgenus). 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 unspecified usa babgenus). Device evaluation/investigation 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, an additional follow- up medwatch will be filed as appropriate.
 
Event Description
A consumer reported an event with unspecified band-aid. A consumer experienced dryness and peeling skin on the heel of foot. Consumer had been applying band-aid, but the inflammation became worse, for which the consumer visited a dermatologist about a month and 10 days prior to this reporting. Since the wound was suppurative, an antibiotic ointment was prescribed, and treatment of the wound was changed to the ointment and gauze. About 10 days later, the prescription was changed from the antibiotic ointment to an ointment in a tube that forms a film. However, the wound did not get better, so the prescription was changed to a petrolatum product called propeto. A different type of bandage was applied by physician's instruction from (b)(6) 2021. On the following day ((b)(6) 2021), as the exudate was overflowing, the consumer replaced the strip with a new one. The consumer stated that the wound looked pink. Next hospital visit was scheduled on (b)(6) 2021.
 
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Brand NameRANGE - ADHESIVE BANDAGES
Type of DeviceDRESSING, WOUND, OCCLUSIVE
Manufacturer (Section D)
JOHNSON & JOHNSON CONSUMER INC
199 grandview road
skillman NJ 08558 9418
Manufacturer (Section G)
COLOPLAST
coloplast hungary kft.
h-4300 nyirbator
coloplast u.2
HU
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key12869117
MDR Text Key285945374
Report Number2214133-2021-00049
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Event Location Other
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/24/2021 Patient Sequence Number: 1
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