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

Model Number 381371161508

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); No Code Available (3191)

Event Date 05/13/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi number: (b)(4)/ upc = (b)(4)/ expiration date = na/ lot number = not reported.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 could not be completed without a lot number.(b)(4); labeling design - part of recall number z-1203-2018 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This incident involves a (b)(6) male consumer using a band-aid brand first aid secureflex wrap (2 x 2.5yd).The consumer reported using a band-aid brand first aid secureflex wrap to secure a traction device on his leg.The consumer started and stopped usage of the product on (b)(6) 2018 and topically applied the wrap once for 6-7 hours.The consumer reported the product irritated his skin, made it scratchy, stinging, and red.The consumer¿s symptoms reduced after he stopped using the product.The consumer did self treat by applying bacitracin to the area.

• Brand Name: JOHNSON & JOHNSON BAND-AID® BRAND OF FIRST AID PRODUCTS SECURE-FLEX® WRAP
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): JOHNSON AND JOHNSON CONSUMER INC.; 199 grandview road; skillman NJ 08858 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: 7639349
• MDR Text Key: 112432857
• Report Number: 2214133-2018-00016
• 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: 05/14/2018

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
• Device Model Number: 381371161508
• Other Device ID Number: (01)381371161508
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 05/14/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 82