MAUDE Adverse Event Report: REWOVEN, INC WILLOW; GARMENT, PROTECTIVE, FOR INCONTINENCE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Dyspnea (1816); Erythema (1840); Itching Sensation (1943); Rash (2033); Swelling (2091)

Event Date 02/17/2019

Event Type  Injury  

Event Description

I used a new urinary incontinence panties product called willow ((b)(6)).After about 12-16 hours of use, i developed a severe rash covering my body from my scalp down to my knees.The rash was intensely red, pruritic, hot to touch, swollen lesions.The palms of my hands and feet were very itchy.I awoke to this rash at 6:00 in the morning.By the time i arrived at the emergency room, i was wheezing and having a difficult time breathing.I was treated with iv steroids, iv fluids and vistaril im.I was discharged with a 5 day burst of prednisone, and discharged home after several hours.Why was the person using the product? urinary incontinence.

• Brand Name: WILLOW
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): REWOVEN, INC
• MDR Report Key: 8366288
• MDR Text Key: 137372378
• Report Number: MW5084279
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 91