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

Model Number 381370056850

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

Patient Problem Burn(s) (1757)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age at time of event, sex, weight, and ethnicity and race were not provided for reporting.This report is for one (1) bab flexible fabric extra large usa (b)(4)usb.Lot # is not available.Udi#: (b)(4) lot number ni; exp date na.Device is not expected to be returned for manufacturer review/investigation.Device evaluation 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 consumer reported an event with band aid flexible fabric extra large usa.Consumer reported that on (b)(6) 2020 the consumer had a surgical procedure performed.Consumer used flexible fabric extra large band-aids to cover the site after the sutures dissolved.Immediately the consumer felt as if the adhesive area of the band-aid was burning the skin.The consumer immediately removed the band-aid and contacted a health care professional (hcp).The consumer visited the hcp on (b)(6) 2020, the same day of the incident.The hcp treated with ointment and told consumer to take over-the-counter allergy medication and said to follow up with surgeon to insure the incision was not affected.

• Brand Name: BAB FLEXIBLE FABRIC EXTRA LARGE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 9707064
• MDR Text Key: 191662515
• Report Number: 2214133-2020-00005
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370056850
• UDI-Public: (01)381370056850
• 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
• Report Date: 01/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 381370056850
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 01/19/2020
• 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