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

Model Number 381370055662

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

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient id, age/date of birth, sex, weight and ethnicity/race were not provided for reporting.The lot number was not reported.The udi number is (b)(4).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 the lot number.Package labeling was reviewed and labeling states: "not made with natural rubber latex".If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A consumer reported an event with bab tough strips waterproof.The consumer stated that after using the bandages, the consumer needed four applications of an epipen.The consumer was transported to the emergency room via ambulance to be treated for anaphylactic shock.The consumer states that the event required three days in the hospital.

• Brand Name: BAB TOUGH STRIPS WATERPROOF EXTRA LARGE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 8874481
• MDR Text Key: 153694341
• Report Number: 8041154-2019-00075
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/18/2019

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: 381370055662
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention