MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-01-16 for BEVELED FLOOR CUSHION 6023 manufactured by Dongguan Posey Medical Device Ltd.
[1015847]
The reporter stated that approximately 6 months ago a patient who had a shuffling gait, when he walked tripped over a posey beveled floor cushion and fell. The patient received a hip fracture. He recovered from the fracture and was discharged from the hospital. The reporter stated that there was no malfunction of the mat. This was due to the patient's shuffling gait.
Patient Sequence No: 1, Text Type: D, B5
[8161701]
No product issue. No prod to be returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2009-00003 |
| MDR Report Key | 1291349 |
| Report Source | 05,06 |
| Date Received | 2009-01-16 |
| Date of Report | 2008-12-18 |
| Date Mfgr Received | 2008-12-18 |
| Date Added to Maude | 2009-01-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | VALERIE CIMMARUSTI |
| Manufacturer Street | 5635 PECK RD. |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Manufacturer G1 | DONGGUAN POSEY MEDICAL DEVICE LTD. |
| Manufacturer Street | FUMIN ROAD, TANGLI VILLAGE FENGGANG TOWN |
| Manufacturer City | DONGGUAN, GUANGDONG |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEVELED FLOOR CUSHION |
| Product Code | LDQ |
| Date Received | 2009-01-16 |
| Model Number | 6023 |
| Catalog Number | 6023 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DONGGUAN POSEY MEDICAL DEVICE LTD |
| Manufacturer Address | GUANGDONG CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-01-16 |