MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-09-18 for GENERIC 180 T565 LH US manufactured by Acorn Stairlifts, Inc..
Report Number | 3003124453-2019-00008 |
MDR Report Key | 9084953 |
Report Source | CONSUMER |
Date Received | 2019-09-18 |
Date of Report | 2019-09-18 |
Date of Event | 2019-08-18 |
Date Mfgr Received | 2019-08-19 |
Device Manufacturer Date | 2017-10-20 |
Date Added to Maude | 2019-09-18 |
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 | 3 |
Event Location | 3 |
Manufacturer Contact | MR. SHAWN HERBST |
Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
Manufacturer City | ORLANDO FL 32809 |
Manufacturer Country | US |
Manufacturer Postal | 32809 |
Manufacturer Phone | 8885650410 |
Manufacturer G1 | ACORN STAIRLIFTS, INC. |
Manufacturer Street | 7001 LAKE ELLENOR DRIVE |
Manufacturer City | ORLANDO FL 32809 |
Manufacturer Country | US |
Manufacturer Postal Code | 32809 |
Single Use | 3 |
Remedial Action | RP |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | GENERIC 180 T565 LH US |
Generic Name | POWER STAIRWAY CHAIRLIFT |
Product Code | PCD |
Date Received | 2019-09-18 |
Returned To Mfg | 2019-08-23 |
Operator | LAY USER/PATIENT |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ACORN STAIRLIFTS, INC. |
Manufacturer Address | 7001 LAKE ELLENOR DRIVE ORLANDO FL 32809 US 32809 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2019-09-18 |