MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J COACH SELF ADHERING SPORTS WRAP; BANDAGE, ELASTIC

Model Number 381370079293

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

Patient Problems Rash (2033); Reaction (2414); No Code Available (3191)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age at time of event, weight, and ethnicity and race was not provided for reporting.Udi #: (b)(4).Upc #: 381370079293, lot #: 3459ca, exp: na.Device is not expected to be returned for manufacturer review/investigation (b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.A review of the device history records has been requested.A review of product labeling was conducted.Labeling states, "caution: this product contains natural rubber latex which may cause allergic reactions." if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A female consumer reported an event with j&j coach self adhering sports wrap.On (b)(6) 2020, consumer used the product for compression on legs.Consumer stated that she had a reaction and rashes, skin flakes, blisters and trouble breathing.Consumer sought medical attention at the hospital.The consumer was treated for her symptoms.The consumer is no longer experiencing any symptoms.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.H4, h6: device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on december 17, 2019.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: J&J COACH SELF ADHERING SPORTS WRAP
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• MDR Report Key: 10356337
• MDR Text Key: 203291521
• Report Number: 2214133-2020-00024
• Device Sequence Number: 1
• Product Code: FQM
• UDI-Device Identifier: 381370079293
• UDI-Public: (01)381370079293(10)3459CA
• 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,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370079293
• Device Lot Number: 3459CA
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention