MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-29 for POISE ULTIMATE EXTRA COVERAGE manufactured by Beijing Beishute Maternity & Child Articles Co,ltd.
[140437202]
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.
Patient Sequence No: 1, Text Type: N, H10
[140437203]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006400113-2019-00001 |
| MDR Report Key | 8466372 |
| Report Source | CONSUMER |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-29 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2019-02-28 |
| Date Added to Maude | 2019-03-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOLENE MEISSNER |
| Manufacturer Street | 2100 WINCHESTER ROAD |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207214177 |
| Manufacturer G1 | BEIJING BEISHUTE MATERNITY & CHILD ARTICLES CO,LTD |
| Manufacturer Street | NO. 1 YUANGUANG STREET, KANGBAO ROAD, BEIJING MIYUN |
| Manufacturer City | ECONOMIC DEVELOPMENT AREA, BEIJING 101500 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 101500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POISE |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2019-03-29 |
| Model Number | ULTIMATE EXTRA COVERAGE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEIJING BEISHUTE MATERNITY & CHILD ARTICLES CO,LTD |
| Manufacturer Address | NO. 1 YUANGUANG STREET, KANGBAO ROAD, BEIJING MIYUN ECONOMIC DEVELOPMENT AREA, BEIJING 101500 CH 101500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2019-03-29 |