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

Model Number 381370047681

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

Patient Problems Reaction (2414); No Code Available (3191)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age at time of event, weight, and ethnicity and race was not provided for reporting.Upc #: (b)(4), lot #: 3519b, exp date: na; udi #: (b)(4).Device is not expected to be returned for manufacturer review/investigation.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 december 17, 2019.(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

A female consumer reported an event with bab sheer large bandage.The consumer had a reaction to the product and reported that blisters appeared all around the area of her leg where she applied the product.The consumer sought medical attention from a health care professional, a dermatologist, and the health care professional prescribed her an unknown antibiotic for treatment.The consumer is still experiencing marks on her leg.

• Brand Name: BAB SHEER 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): 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: 10271504
• MDR Text Key: 199123873
• Report Number: 8041154-2020-00017
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370047681
• UDI-Public: (01)381370047681(10)3519B
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 381370047681
• Device Lot Number: 3519B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention