MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J BAND AID BRAND CUSHION CARE SPORTS STRIP; ADHESIVE BANDAGE

Model Number 381370045373

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

Patient Problems Erythema (1840); Pain (1994); Local Reaction (2035); Impaired Healing (2378); Skin Inflammation/ Irritation (4545)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Ethnicity and race were not provided for reporting.Udi: (b)(4).Upc- (b)(4).Expiration date-na.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A (b)(6) female consumer stated she used band-aid extra wide sport strip to cover a surgical wound that was draining to protect their clothing and bedding.The consumer stated they had a very bad reaction to the bandage.Consumer stated the area was reddened and is slightly larger than a quarter.The consumer used non-stick gauze and sensitive skin tape to cover the area and protect from rubbing her clothes.Loose fitting clothes were also worn to avoid irritation and pain from the event.The consumer stated she sought medical intervention and was seen by two health care professionals (hcp) on two separate occasions.The hcps examined the area and recommended the consumer apply bacitracin to the wound and contact the physicians again if the condition has worsened.The symptoms improved after product was last used and consumer was still experiencing symptoms while reporting this event.

• Brand Name: J&J BAND AID BRAND CUSHION CARE SPORTS STRIP
• Type of Device: ADHESIVE BANDAGE
• 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: 12375593
• MDR Text Key: 268453145
• Report Number: 8041154-2021-00025
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370045373
• UDI-Public: (01)381370045373(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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370045373
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/17/2021
• 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
• Patient Age: 62 YR