MAUDE Adverse Event Report: BEIJING BEISHUTE MATERNITY & CHILD ARTICLES CO,LTD POISE; GARMENT, PROTECTIVE, FOR INCONTINENCE

Model Number ULTIMATE EXTRA COVERAGE

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

Patient Problems Fever (1858); Gangrene (1873); Pain (1994); Sepsis (2067); Discomfort (2330)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

A manufacturer lot code was not provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.

Event Description

Consumer's daughter reported she took her mother to the er due to discomfort and fever and she was diagnosed with a gangrenous lesion and sepsis.The er doctor told her the lesion was from the poise pad.The outer seal of the pad rubbed her skin and caused the lesion on her lower abdomen near the pubic bone.Surgery was performed the same day to remove the lesion and clean out the gangrene.She was then admitted to the hospital and given iv antibiotics.She was discharged six days later to a nursing home for rehabilitation.She received wound care while there.She was discharged to her own home a month and a half later.She is improving but is still in pain and healing from the infection.She continues to have an open wound that her daughter cleanses with a saline solution mixed with peroxide and packs with saline saturated gauze and an oil based gauze daily with antibiotic ointment.She has had regular follow ups with the surgeon.At her last follow up the surgeon confirmed she was healing well.She did state her wound is bleeding and the surgeon has been cauterizing it during her routine follow ups.She will continue to follow up with surgeon every three weeks.

• Brand Name: POISE
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): BEIJING BEISHUTE MATERNITY & CHILD ARTICLES CO,LTD; no. 1 yuanguang street,; kangbao road, beijing miyun; economic development area, beijing 10150 0; CH 101500
• Manufacturer (Section G): BEIJING BEISHUTE MATERNITY & CHILD ARTICLES CO,LTD; no. 1 yuanguang street,; kangbao road, beijing miyun; economic development area, beijing 10150 0; CH 101500
• Manufacturer Contact: jolene meissner ; 2100 winchester road; neenah, WI 54956 ; 9207214177
• MDR Report Key: 8466372
• MDR Text Key: 140437202
• Report Number: 3006400113-2019-00001
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE EXTRA COVERAGE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 72 YR