MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB TOUGH STRIPS; TAPE AND BANDAGE, ADHESIVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Tears (2516); Presyncope (4410)

Event Date 11/24/2022

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 weight, and ethnicity and race were not provided for reporting.This report is for one (1) band-aid tough strips unspecified usa not applicable batgztusunsp batgztusunsp, lot number ni.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.Health effect clinical code: (b)(6) also refers to consumer alleged about "ripped the skin off of each side of wound , bleeding of his skin, subsumed pain".(b)(6) also refers to consumer alleged about "almost passed out from the pain".If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The consumer's wife reported on behalf of her husband that he cut his hand and used one of the unspecified band-aid tough strip on (b)(6) 2022.It ripped the skin off of each side of the wound when he was trying to remove the band-aid.It was so bad that he had to go to the emergency room (er) to prevent more tearing and bleeding of his skin.He almost passed out from the pain.After the er doctor removed the band-aid, the skin was literally torn off of his hand where the sticky part is, the doctor used a gauze and wrap dressing.He also used an antibiotic cream.It was reported that the patient symptoms have improved while reporting this event.

• Brand Name: BAB TOUGH STRIPS
• 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 Key: 15987054
• MDR Text Key: 305513197
• Report Number: 2214133-2022-00053
• Device Sequence Number: 1
• Product Code: KGX
• 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
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• 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
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male