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

Model Number 381371150786

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 and 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.A2, a4, a5: age at time of event, weight, and ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for one (1) bab flexible fabric assorted 100 ct usa 381371150786.8137115078 usa, lot number 210608.D4: udi #: (b)(4), upc # (b)(4).Expiration date: na.Lot number #: 210608.D10: device is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.H6: health effect clinical code: e0402 also refers to consumer alleged about "allergic reaction diagnosed by health care professional (red, swollen, rash, itching subsumed)".E2402 refers to consumer."intentional misuse/off-label use" of the product.This is two of two med watches being submitted as two devices were involved in this event.See medwatch 1000599868-2023-00010.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

The fda reported an event, via mw5120206, regarding a male consumer that alleged an allergic reaction to the adhesive on flexible fabric band-aid.The skin under the adhesive parts became red, inflamed, and had a rash.The entire wound area became redder and swollen.The original wound was an abrasion and scratch with some blood, but not bleeding on the shin of the left leg.Consumer washed it, applied bacitracin zinc ointment, and covered it with a large band-aid twice a day, then once per day.As wound area became redder and more itchy, he thought there was an infection and was more diligent at replacement.Consumer contacted unknown center and sent a picture of wound.The consumer was advised to uncover the wound and stop using the band-aid and ointment.He then visited the outpatient clinic and was told what happened was likely an allergic reaction to the adhesive on the band-aids.Over the weekend, the reddened areas clearly showed the pattern of the band-aid wings.The rash is still present, but improving.Consumer stated that the adverse event required intervention.This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 1000599868-2023-00010.The same patient is represented in each medwatch.

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 june 08, 2021.Raw material and component records were reviewed and were found acceptable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This is two of two medwatch follow-ups being submitted as three devices were involved in this event.See medwatch 1000599868-2023-00010.The same patient is represented in each medwatch follow-up.

• Brand Name: BAB FLEXIBLE FABRIC 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): SHANGHAI JOHNSON & JOHNSON LTD; 120 nan ya road; minghang, shanghai 20024 5; CH 200245
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 17755015
• MDR Text Key: 323492352
• Report Number: 1000599868-2023-00011
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371150786
• UDI-Public: (01)381371150786(10)210608
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

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: 381371150786
• Device Lot Number: 210608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male