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

Model Number 381370044444

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

Patient Problems Erythema (1840); Scar Tissue (2060); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

A consumer reported an event with band aid flexible fabric 1in.Consumer applied band aid flexible fabric on a wound and alleged it made it worse.Consumer stated that the entire area of the wound was red and swollen and awful.The consumer had to go to a doctor who confirmed it was caused by the band aid.It was reported that, the consumer needed to be treated with steroids for a minimum of four weeks and the scarring maybe permanent.

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.Patient age at time of event, gender, weight, and ethnicity and race were not provided for reporting.This report is for one (1) bab flexible fabric 1in 100s usa 381370044444 8137004444usa 8137004444usa, lot number 220809.Udi #: (b)(4).Upc #: 381370044444.Lot #: 220809.Expiration date: na.Device is not expected to be returned for manufacturer review/investigation.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 august 9, 2022.Health effect clinical code: e2338 also refers to consumer alleged about "reaction described as wound got worse and awful.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 COMPANY 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: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 16761010
• MDR Text Key: 313498855
• Report Number: 1000599868-2023-00004
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370044444
• UDI-Public: (01)381370044444(10)220809
• 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: 03/29/2023

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: 381370044444
• Device Lot Number: 220809
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention