MAUDE Adverse Event Report: BRAZIL CONSUMER BAB TOUGH STRIPS EXTRA LARGE 10S USA; ADHESIVE BANDAGES

Model Number 381370044246

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

Patient Problems Scarring (2061); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4), lot number=2288b.Device is not expected to be returned for manufacturer review/investigation.Device was used for treatment, not diagnosis.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 17, 2018.If information is obtained that was not available for this follow-up medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

A (b)(6) year old, (b)(6) male consumer reported that while using bab tough strips extra large for two weeks, he had an allergic reaction to the product.Consumer stated he had a mark on his leg from the bandage.Consumer also stated that he had more damage to the original wound.The consumer sought medical attention and received treatment.The physician recommended applying hydrocortisone cream to the site twice a day.Consumer stated the doctor felt the imprint/red mark/scar would not go away.The consumer was not admitted to the hospital.It is unknown if the symptoms have resolved.

• Brand Name: BAB TOUGH STRIPS EXTRA LARGE 10S USA
• Type of Device: ADHESIVE BANDAGES
• Manufacturer (Section D): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer (Section G): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: linda plews ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 8464888
• MDR Text Key: 140329419
• Report Number: 8041154-2019-00042
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 381370044246
• Device Lot Number: 2288B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 91