MAUDE Adverse Event Report: JOHNSON & 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); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot number = unknown.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 lot number.(b)(4) - 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

Consumer reported some itching and red bumps after using johnson and johnson band-aid secure flexcare wrap.Consumer, started using them (b)(6) 2017 and is still using them.Additionally, to treat the itching and bumps consumer used hydrocortisone cream and put the wrap over a sock.Consumer is using it for pain caused by erythema and small vesicles and does consider himself recovered.

• 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 road; 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: 7638709
• MDR Text Key: 112870719
• Report Number: 2214133-2018-00014
• 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: 01/04/2018

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: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Removal/Correction Number: Z1203-2018
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 73