MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND-AID PLUS NEOSPORIN; ADHESIVE BANDAGES

Model Number 381370055693

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

Patient Problems Ischemia (1942); No Code Available (3191)

Event Date 11/19/2019

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 antibiotic 20s usa 381370055693 8137005569usa 8137005569usa.Upc #: 381370055693, lot #: 2519b, udi #: (b)(4).Device is not expected to be returned for manufacturer review/investigation.Concomitant products: metformin ¿ diabetes treatment, strength unknown, frequency unknown, dates used unknown; aspirin ¿ treatment unknown, strength unknown, frequency unknown, dates used unknown.This product was manufactured in 08.Sep.2009.Device history records review was unable to be completed.Based on the dynamic trend review no lot trend was identified for the reported aes.This product has exceeded the manufacturing site¿s retention period for dhr.(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

Male consumer reported his foot is irritated and also experienced redness by the band aid product.Consumer visited hospital and the doctor cleaned his wound.Consumer was also given an antibiotic for the treatment.

• Brand Name: BAND-AID PLUS NEOSPORIN
• Type of Device: ADHESIVE BANDAGES
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 9475817
• MDR Text Key: 182743107
• Report Number: 8041154-2019-00091
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370055693
• UDI-Public: (01)381370055693(10)2519B
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370055693
• Device Lot Number: 2519B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 127