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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 Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/07/2021
Event Type  Injury  
Event Description
A consumer reported an event with an unknown band aid bandage. On (b)(6) 2021, the consumer received a wound from a shaver. As the area swelled and became like a wart, the consumer applied the unknown band-aid bandage. The consumer scratched it and it bled and the bleeding would not stop. Since the hospital was closed and the bleeding did not stop, the consumer consulted a pharmacist at a pharmacy and applied terramycin (oxytetracycline hydrochloride/polymixin b sulfate) and placed band-aid on it. On the day of this reporting, the bleeding stopped and the event has resolved.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. This report is for (range - adhesive bandages ap not applicable 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. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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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)
JOHNSON & JOHNSON CONSUMER INC
199 grandview road
skillman NJ 08558 9418
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key13060078
MDR Text Key282615136
Report Number2214133-2021-00053
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 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
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 Received12/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/22/2021 Patient Sequence Number: 1
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