MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB FLEXIBLE FABRIC EXTRA LARGE; ADHESIVE BANDAGES

Model Number 381370056850

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

Patient Problems Peeling (1999); No Code Available (3191)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient ethnicity and race was not provided for reporting.This report is for one bab flexible fabric extra large usa 381370056850 8137005685usb 8137005685usb.Upc #: (b)(4), lot #: 190202, udi #: (b)(4).Upc = (b)(4).Expiration date= na.Lot number = 190202.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.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.Device manufacture date 02/02/2019.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A male consumer reported an event with bab flexible fabric extra large.The consumer called to inquire on how to remove the adhesive from his skin.Consumer is diabetic and has blisters on his legs.The surface is smooth like glass and the glue is cracking in bits but when the consumer scratched it, it bled.Consumer visited a health care professional for treatment.The consumer is still experiencing symptoms.

• Brand Name: BAB FLEXIBLE FABRIC EXTRA LARGE
• Type of Device: ADHESIVE BANDAGES
• 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: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 9510929
• MDR Text Key: 188832861
• Report Number: 1000599868-2019-00014
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370056850
• UDI-Public: (01)381370056850(10)190202
• 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: 12/06/2019

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: 381370056850
• Device Lot Number: 190202
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 84