MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-27 for UPEASY CCFUPE1 manufactured by Ningbo South Industrial Co., Ltd..
[131536768]
The end-user was trying to sit in his dining room table chair. All of the sudden, the (initial reporter of complaint) end-user's wife heard a boom, and heard the end-user scream. The end-user's wife went into the dining room, and found him on the floor. She said that her "huband" was trying to sit down, and the seat was stuck in the up position, and since he was trying to push the seat down, it kicked him off, and he fell & got hurt. She had to call 9-1-1 because she was not able to pick him up - he bumped his head, and his eye, cheek, & neck are black and blue. He was in the hospital for 3 days due to the fall, and they were checking to ensure he had no internal injuries. No other injuries were noted. Serial/lot# information provided: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00066 |
| MDR Report Key | 8200237 |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-12-17 |
| Date Facility Aware | 2018-12-17 |
| Report Date | 2018-12-27 |
| Date Reported to FDA | 2018-12-27 |
| Date Reported to Mfgr | 2018-12-27 |
| Date Added to Maude | 2018-12-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UPEASY |
| Generic Name | SEAT ASSIST |
| Product Code | INN |
| Date Received | 2018-12-27 |
| Model Number | CCFUPE1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NINGBO SOUTH INDUSTRIAL CO., LTD. |
| Manufacturer Address | FENGCHENG VILLAGE JISHIGANG TOWN YINZHOU, 315171 CH 315171 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-12-27 |