MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB CLEAR WATER BLOCK PLUS; TAPE AND BANDAGE, ADHESIVE

Model Number 381370056591

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

Patient Problems Bruise/Contusion (1754); Burn(s) (1757); Hypersensitivity/Allergic reaction (1907); Rash (2033); Scar Tissue (2060); Contact Dermatitis (4546); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight, and ethnicity and race were not provided for reporting.This report is for one (1) bab clear water block plus 30s usa 381370056591, 8137005659usa, lot number 2688b.Udi: (b)(4), upc - 381370056591, lot number ¿ 2688b, exp- na.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.(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

Consumer reported and event with band aid bandage clear water block plus.The consumer used product on her arm on (b)(6) 2021 because she got an insect bite and she did not want to scratch it.She used it overnight but when she took it off on (b)(6) 2021, it was stuck and left a mark on her skin and also was bruised.The consumer alleges that she experienced an allergic reaction.Consumer alleged, band aid burning and scarring her right shoulder.The consumer sought medical attention.The rash is burning moderate in severity.The rash has been present for 1 week.Based on dermatology report, the consumer was potentially diagnosed with irritant contact dermatitis and brown scaly patches.Consumer was also recommended to use paper tape instead of band-aids.Consumer was prescribed triamcinolone acetonide 0.1% topical ointment tp for treatment.

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 september 25, 2018.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow- up medwatch will be filed as appropriate.

• Brand Name: BAB CLEAR WATER BLOCK PLUS
• 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: 12853942
• MDR Text Key: 285362195
• Report Number: 8041154-2021-00037
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370056591
• UDI-Public: (01)381370056591(10)2688B
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370056591
• Device Lot Number: 2688B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female