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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J BAND AID BRAND FIRST AID WATERBLOCK TAPE / WATERPROOF; TAPE AND BANDAGE, ADHESIVE

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JOHNSON & JOHNSON CONSUMER INC J&J BAND AID BRAND FIRST AID WATERBLOCK TAPE / WATERPROOF; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Model Number 381371171217
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Urticaria (2278); Caustic/Chemical Burns (2549); Fluid Discharge (2686); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/27/2023
Event Type  Injury  
Event Description
It was reported that consumer bought, band-aid water block medical tape to secure her dressings after the abdominal surgery on (b)(6) 2023.Consumer used tape to secure the bandages for her abdomen.Within about 3-4 hours, her skin felt horrible under the tape.It was burning and itching like it was developing a series of hives.Consumer took off the dressings and tape and discovered that, tape had literally caused 6 different chemical burns along where it was on her abdomen and the top layers of skin had been melted off.They range in size from around 2 inches long to about the size of a quarter, they ooze constantly, burn, sting, and feel excruciating during shower and when water hits the burned area.Consumer also reported having redness and rash symptoms.The symptoms did not improve after the consumer stopped using the product.The consumer visited a health care professional (hcp) for the treatment and prescribe an ssd burn cream for 6 different burns.The consumer also cleans the area with soap and water but still there was residue.Consumer also used hydrogen peroxide, unknown cream and a bandage to cover the wound.
 
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 weight, and ethnicity and race were not provided for reporting.This report is for one j&j band aid brand first aid waterblock tape 1in usa 381371171217 381371171217usa 381371171217usa, lot number 1802h.Udi #: (b)(4).Upc #: 381371171217.Lot #: 1802h.Exp date: ni.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.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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 an 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.H4, h6: device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on june 22, 2022.Raw material and component records were reviewed and were found acceptable.D1103: cause traced to intentional off-label use.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 Name
J&J BAND AID BRAND FIRST AID WATERBLOCK TAPE / WATERPROOF
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
JOHNSON & JOHNSON CONSUMER INC
199 grandview rd
skillman 08558 9418
Manufacturer (Section G)
DUKAL HUAZHOU QIDONG ¿ CHINA
no.2858, huazhou rd, airport
pudong new district
shanghai
CH  
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key17008088
MDR Text Key315992059
Report Number2214133-2023-00014
Device Sequence Number1
Product Code KGX
UDI-Device Identifier381371171217
UDI-Public(01)381371171217(10)1802H
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,Followup
Report Date 05/26/2023
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
Device Model Number381371171217
Device Lot Number1802H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 05/05/2023
Initial Date FDA Received05/25/2023
Supplement Dates Manufacturer Received05/26/2023
Supplement Dates FDA Received06/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2022
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age39 YR
Patient SexFemale
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