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 Problems Skin Erosion (2075); Skin Tears (2516); Skin Infection (4544)

Event Date 05/27/2022

Event Type  Injury  

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.This report is for one (1) bab flexible fabric extra large usa 381370056850, lot/ctrl # 210531.Udi #: (b)(4); upc #: 381370056850; lot #: 210531; 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 may 31, 2021.This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 1000599868-2022-00010.The same patient is represented in each medwatch.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 a band aid flexible fabric extra large bandages.Consumer started using flexible fabric large band aid on (b)(6) 2022 for wound care.Consumer alleges that dirt, perspiration and other items got under the bandage and the wound got infected on (b)(6) 2022.Consumer stated that the scab came off when he removed the band-aid, and his wound is still infected and leaking white puss.After he stopped using the band-aid the wound got worse, it got larger, and he has an outline of where the adhesive was.His skin is all broken down where the adhesive was.Consumer¿s wife, who is an icu nurse, cleaned the area and put an unspecified antibiotic ointment and re-bandaged it.Consumer is still not recovered at time of reporting.This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 1000599868-2022-00010.The same patient is represented in each medwatch.

• 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): SHANGHAI, CHIN; 120 nan ya road; minghang, shanghai
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 14798954
• MDR Text Key: 295110577
• Report Number: 1000599868-2022-00009
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370056850
• UDI-Public: (01)381370056850(10)210531
• 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: 06/02/2022

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: 210531
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male