MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-10-19 for DRIVE MEDICAL 10200-1 NA manufactured by Fort Metal Plastic Co. Ltd..
[3027083]
Fort has received a notification of mdr report from (b)(4), our distributor in the us, about updated information from an attorney on the patient injury from a previous complaint involving a folding walker allegedly manufactured by fort. It is alleged that the claimant was walking with the walker when the leg snapped causing him to fall and sustain permanent irreversible damage to the triceps area. (b)(4) had reached out to the claimant's attorney to have photos of the alleged product. (b)(4) has also requested claimant's medical records or details on the injury, but not response has been received. This mdr report is based on the complaint from the claimant's attorney and the dealer where the walker was purchased by the claimant, as well as (b)(4)'s mdr report.
Patient Sequence No: 1, Text Type: D, B5
[10270738]
Since the alleged device was not returned to fort or our distributor, we are unable to confirm and evaluate the alleged defect.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006984916-2012-00003 |
| MDR Report Key | 2824239 |
| Report Source | 08 |
| Date Received | 2012-10-19 |
| Date of Report | 2012-09-24 |
| Date of Event | 2011-07-01 |
| Date Mfgr Received | 2012-09-24 |
| Device Manufacturer Date | 2010-12-07 |
| Date Added to Maude | 2012-11-09 |
| 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 | JOHN XU |
| Manufacturer Street | YI HE CIVIL AFFAIRS INDUSTRIAL AREA |
| Manufacturer City | LUOYANG TOWN, HUIZHOU CITY, GUANGDONG PR |
| Manufacturer Country | CH |
| Manufacturer Phone | 26865366 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | MECHANICAL WALKER |
| Product Code | INB |
| Date Received | 2012-10-19 |
| Model Number | 10200-1 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FORT METAL PLASTIC CO. LTD. |
| Manufacturer Address | GUANGDONG CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-19 |