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

Model Number 381370046691

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

Patient Problems Skin Discoloration (2074); Skin Burning Sensation (4540)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age at time of event, gender, weight and ethnicity were not provided for reporting.Udi: (b)(4).Upc = (b)(4).Expiration date= na.Lot number =ni.This report is for one (1) bab sheer assorted 80s usa 381370046691 8137004669usa 8137004669usa, lot number ni.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.The consumer has reported a band aid was used and may have contributed to the event, the following products are possible devices that were used from this kit (j&j first aid all purpose kit 140 pc usa 381371030095): bab sheer assorted 80s, 8137004669usa.- lot ni.Bab clear water block plus 30s, 8137005659usa.- lot ni.This is 1 of 2 med-watches for bab sheer assorted 80s, 8137004669usa being submitted as two possible devices were involved in this event.See medwatch 8041154-2021-00020 for bab clear water block plus 30s, 8137005659usa.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a consumer had discoloration and burning after use of a band aid product.Consumer sought medical attention after using product.No further patient information was provided.This is 1 of 2 med-watches for bab sheer assorted 80s, 8137004669usa being submitted as two possible devices were involved in this event.See medwatch 8041154-2021-00020 for bab clear water block plus 30s, 8137005659usa.The same patient is represented in each medwatch.

• 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: 12177993
• MDR Text Key: 261911884
• Report Number: 8041154-2021-00019
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370046691
• UDI-Public: (01)381370046691(10)NI
• 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: 07/08/2021

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: 381370046691
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention