MAUDE Adverse Event Report: JOHNSON AND JOHNSON CONSUMER INC. BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX

Model Number 381371183494

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

Patient Problems Burn(s) (1757); Scarring (2061)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Medical device: udi: (b)(4), upc = (b)(4), expiration date= ni, lot number = 0509b.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 february 19, 2019.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) year old female consumer reported after using band aid brand adhesive bandage skin flex to cover a cut, the product gave her burns and a scar on her leg.The consumer went to a doctor and was prescribed silvadene burn cream to treat the burn.

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.Corrected data: a1.Additional data: section a : the patient¿s height was reported as 5' 11.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Based on additional information reported on july 10, 2021.It was reported that the consumer's symptoms did not improve after stopping use of the product and was still experiencing the symptoms while reporting this event.

• Brand Name: BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX
• Type of Device: ADHESIVE BANDAGE
• Manufacturer (Section D): JOHNSON AND JOHNSON CONSUMER INC.; 199 grandview road; skillman NJ 08858 9418
• MDR Report Key: 9140922
• MDR Text Key: 167087931
• Report Number: 8041154-2019-00081
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371183494
• UDI-Public: (01)381371183494(10)0509B
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381371183494
• Device Lot Number: 0509B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 07/10/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 98