MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-29 for LUMEX 6140A manufactured by Bliss Health Products Co. Ltd.
[55900227]
Patient Sequence No: 1, Text Type: N, H10
[55900228]
On (b)(6) 2016: the end-user's attorney stated his disabled client was using the quad cane while ambulating within his apartment when the cane suddenly bent causing him to fall face forward onto the floor, resulting in a bruise/ contusion to his chest and shoulder. On (b)(6) 2016: gf health products, inc. Received written documentation alleging the end-user has a 10% permanent disability rating related to the (b)(6) 2016 fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428983-2016-00001 |
| MDR Report Key | 5986609 |
| Date Received | 2016-09-29 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-04-14 |
| Date Facility Aware | 2016-08-26 |
| Report Date | 2016-09-28 |
| Date Reported to FDA | 2016-09-28 |
| Date Reported to Mfgr | 2016-06-30 |
| Date Added to Maude | 2016-09-29 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | LUMEX |
| Generic Name | WALKCANE |
| Product Code | IPS |
| Date Received | 2016-09-29 |
| Model Number | 6140A |
| Lot Number | BMR291MO |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLISS HEALTH PRODUCTS CO. LTD |
| Manufacturer Address | ZHONGSHAN CITY, GUANDONG CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-09-29 |