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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB FLEXIBLE FABRIC BANDAGES; TAPE AND BANDAGE, ADHESIVE

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JOHNSON & JOHNSON CONSUMER INC BAB FLEXIBLE FABRIC BANDAGES; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033)
Event Type  Injury  
Manufacturer Narrative
Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes and admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Patient identifier, age at time of event, gender, weight, and ethnicity and race were not provided for reporting.This report is for one (1) band-aid flexible fabric bandages unspecified usa notapplicable bafxxbusunsp bafxxbusunsp, lot number n/a.Upc, lot number and udi are not available.Device is not expected to be returned for manufacturer review/investigation.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.Out of an abundance of caution this event is being reported.Since 2017, the product packaging for this product family states, ¿not made with natural rubber latex¿.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Consumer reported an event with band aid flexible fabric bandages.Consumer developed a rash where the bandage was that then spread up the consumer¿s hand.Consumer had to go to urgent care for an antihistamine shot just to get skin to calm down.The consumer stated that the itchiness was unbearable.There is no additional information regarding this event.
 
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Brand Name
BAB FLEXIBLE FABRIC BANDAGES
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
JOHNSON & JOHNSON CONSUMER INC
199 grandview rd
skillman NJ 08558 9418
Manufacturer (Section G)
JOHNSON & JOHNSON CONSUMER INC
199 grandview rd
skillman NJ 08558 9418
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key16146770
MDR Text Key307178650
Report Number2214133-2023-00001
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 12/16/2022
Initial Date FDA Received01/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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