MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID WATERBLOCK BANDAGES; ADHESIVE BANDAGES

Model Number 381370056584

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

Patient Problems Pain (1994); Scarring (2061); Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided for reporting.This report is for (band-aid waterblock large 10s can 381370056584).Device is not distributed in the united states, but is similar to device marketed in the usa (bab water block plus 3/4in 30s usa 381370056423).Udi #: (b)(4).Expiration date= na.Report source: device is not distributed in the united states, but is similar to device marketed in the usa (bab water block plus 3/4in 30s usa 381370056423).Device history records review was completed.No non-conformances 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.This product was manufactured on october 25, 2018.(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

This event was reported by a female consumer after using a band-aid waterblock large bandage to cover stitches on her arm received as a result of a dog bite.The product was applied on (b)(6) 2019 and was used for 24 hours.The consumer indicated they were using the product to keep the area dry while showering.The consumer noted skin was removed upon removal of the product and left a ¿burned looking outline¿ on the skin and consumer was in pain.Scabs were also reported where the skin was removed.The consumer indicated that symptoms did not improve after stopping usage of the product and was continuing to experience scarring as a result of the event.The consumer indicated they applied polysporin and consulted a health care professional (hcp) about the experience.The hcp prescribed a cortisone cream as treatment.

• Brand Name: BAND AID WATERBLOCK BANDAGES
• Type of Device: ADHESIVE BANDAGES
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 99 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: 9009785
• MDR Text Key: 160443189
• Report Number: 8041154-2019-00078
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370056584
• UDI-Public: (01)381370056584(10)2988B
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 08/17/2019

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: 381370056584
• Device Lot Number: 2988B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/17/2019
• Initial Date FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 82