MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J FIRST AID HURT-FREE WRAP; BANDAGE, ELASTIC

Model Number 381370049029

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

Patient Problems Pain (1994); Peeling (1999)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided for reporting.This report is for one (1) j&j first aid hurt-free wrap 2inx2.3yd usa 381370049029 8137004902usa 8137004902usa.Lot # is not available.Udi# (b)(4).Device is not expected to be returned for manufacturer review/investigation.Device evaluation 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A mother reported an event on behalf of her son with j&j first aid hurt-free wrap 2inx2.The mother had to wrap her son¿s elbow.The product was stuck to his hair and skin peeling the hairs off, which was painful, but it also peeled away a steri-strip that should not have come off.Consumer had to visit urgent after using the product for treatment (reapplied steri-strip to elbow that product removed).Consumer reported his son was in stable condition and not experiencing any symptoms while reporting this event.

• Brand Name: J&J FIRST AID HURT-FREE WRAP
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): CAREMAX CO.,LTD; no. 43 shuangjing street; wei ting town, industrial park; suzhou 21512 1; CH 215121
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 10540094
• MDR Text Key: 207123457
• Report Number: 2214133-2020-00034
• Device Sequence Number: 1
• Product Code: FQM
• UDI-Device Identifier: 381370049029
• UDI-Public: (01)381370049029(10)NI
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370049029
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention