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

Model Number 381371150786

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

Patient Problems Scar Tissue (2060); Skin Tears (2516); Skin Inflammation/ Irritation (4545); Easy Bruising (4558); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A male consumer reported an event with band-aid flexible fabric bandage when used on his sores.He experienced irritation and torn skin on the last band aid he applied.The band-aid left a bruise like a scar on his leg and an open wound on his arm.Consumer contacted health care professional (hcp) and was prescribed mupricin ointment, gauze and bactrim pills for the 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 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.A4, a5: patient 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 8137115078usa 8137115078usa, lot number 220312.D4: udi #: (b)(4).Upc # 381371150786.Expiration date: na.Lot number #: 220312.D10: device is not expected to be returned for manufacturer review/investigation.H3, 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 march 12, 2022.H6: health effect clinical code: e2402 refers to consumer "intentional misuse/off-label use" of the product.E1721 also refers to consumer alleged about "skin tear due to which open wound".If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 17798339
• MDR Text Key: 324031034
• Report Number: 1000599868-2023-00012
• Device Sequence Number: 1
• Product Code: KGX
• 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: 08/30/2023

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: 220312
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male