MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC JOHNSON & JOHNSON BAND-AID® BRAND OF FIRST AID PRODUCTS SECURE-FLEX® WRAP; BANDAGE, ELASTIC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Ischemia (1942)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age, weight and ethnicity was not provided for reporting.This report is for one (1) johnson and johnson band-aid® brand of first aid products secure-flex wrap, lot # and udi# is not available.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 could not be completed without lot number.(b)(4) - part of recall numbers z-1203-2018 and z-1204-2018.This report is for one (1) unknown johnson and johnson band-aid® brand of first aid products secure-flex® wrap: z-1204-2018 - johnson and johnson band-aid® brand first aid products secure-flex® wrap (size: 3 in), z-1203-2018 - johnson and johnson band-aid® brand first aid products secure-flex® wrap (size: 2 in).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A wife called to report her husband used the secure-flex wrap and his skin was irritated.No additional information has been provided.

• Brand Name: JOHNSON & JOHNSON BAND-AID® BRAND OF FIRST AID PRODUCTS SECURE-FLEX® WRAP
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; nj; skillman NJ 08558 9418
• Manufacturer (Section G): CAREMAX; no. 43, shuang jing street; feng ting rd,; sip, jiangsu, p.r. 21512 1; CH 215121
• Manufacturer Contact: linda plews ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 7638532
• MDR Text Key: 112850953
• Report Number: 2214133-2018-00013
• Device Sequence Number: 1
• Product Code: FQM
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z1203-2018
• Patient Sequence Number: 1