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

Model Number 381370079286

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

Patient Problems Ischemia (1942); Itching Sensation (1943); Pain (1994)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient ethnicity and race was not provided for reporting.(b)(4).Expiration: na.Lot number: 2547car.Device is not expected to be returned for manufacturer review/investigation.Concomitant medical products and therapy dates: drug: cetirizine; 10 mg, 1x daily; 3 years; to treat allergies; consumer still on drug.Drug: other unknown medications.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review have been requested.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A (b)(6), female consumer reported that she used johnson and johnson coach self adhering sports wrap for the first time on (b)(6) 2018 for a sprained ankle.Consumer reported that she wrapped her sprained ankle with the product for up to 12 hours.Within the same day, the consumer started to experiencing irritation around her ankle and wearing the product started to get uncomfortable and removed the product.On (b)(6) 2018, the affected area was irritated, itchy and had blisters all around the ankle where the product was wrapped.Consumer reported she did not medically treat the area but did indicate she kept the area clean until she saw her podiatrist who diagnosed her with contact dermatitis.The hcp prescribed the consumer to apply fluocinonide cream to the affected area as a treatment.Consumer reported she applied the fluocinonide cream as needed.Consumer reported that her symptoms are resolving but does still experience some irritation and on occasion will have itching in the area.

Manufacturer Narrative

Device was used for treatment, not diagnosis.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 september 11, 2017.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: 7834685
• MDR Text Key: 118871097
• Report Number: 2214133-2018-00043
• Device Sequence Number: 1
• Product Code: FQM
• 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: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370079286
• Device Lot Number: 2547CAR
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/17/2018
• Patient Sequence Number: 1
• Treatment: CETIRIZINE, 10MG, 1X DAILY; OTHER UNKNOWN MEDICATIONS
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 70