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

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.

• 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 Key: 17008088
• MDR Text Key: 315992059
• Report Number: 2214133-2023-00014
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371171217
• UDI-Public: (01)381371171217(10)1802H
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: 381371171217
• Device Lot Number: 1802H
• 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 Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female