MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-09-07 for DRIVE COBRAGT420CS manufactured by .
[119645536]
A 2438477-2015-00006. (b)(4) has received a complaint from the claimant on an incident allegedly involving a power scooter imported and distributed by drive medical. The claimant states that the claimant was thrown from the scooter while riding on the sidewalk which caused him to re-injure his left shoulder, rib cage, and right hip. We have reached out to the claimant to obtain further information regarding injuries. This mdr report is based on the information provided by the claimant and the device provider.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616873-2015-00001 |
| MDR Report Key | 7855890 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-06 |
| Date of Event | 2015-01-21 |
| Date Facility Aware | 2015-01-22 |
| Date Mfgr Received | 2015-02-20 |
| Device Manufacturer Date | 2014-05-23 |
| Date Added to Maude | 2018-09-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TIM KAO |
| Manufacturer Street | NO. 225, YUAN-PIER ST. HSIN CHU CITY, |
| Manufacturer City | TW-HSQ, 30093 |
| Manufacturer Country | TW |
| Manufacturer Postal | 30093 |
| Manufacturer G1 | WU'S TECH |
| Manufacturer Street | NO. 225, YUAN-PIER ST. HSIN CHU CITY, |
| Manufacturer City | TW-HSQ, 30093 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 30093 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | POWER SCOOTER |
| Product Code | INI |
| Date Received | 2018-09-07 |
| Model Number | COBRAGT420CS |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-07 |