MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-16 for MAXI 500 KM560181 manufactured by Arjohuntleigh Magog Inc..
Report Number | 9681684-2020-00020 |
MDR Report Key | 9835255 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2020-03-16 |
Date of Report | 2020-03-16 |
Date of Event | 2020-02-20 |
Date Mfgr Received | 2020-02-20 |
Device Manufacturer Date | 2016-12-21 |
Date Added to Maude | 2020-03-16 |
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 | KINGA STOLINSKA |
Manufacturer Street | KS. WAWRZYNIAKA 2 |
Manufacturer City | KOMORNIKI 62-052 |
Manufacturer Country | PL |
Manufacturer Postal | 62-052 |
Manufacturer Phone | 688282467 |
Manufacturer G1 | ARJOHUNTLEIGH MAGOG INC. |
Manufacturer Street | 2001 TANGUAY STREET |
Manufacturer City | MAGOG, QUEBEC J1X 5Y5 |
Manufacturer Country | CA |
Manufacturer Postal Code | J1X 5Y5 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MAXI 500 |
Generic Name | LIFT, PATIENT, NON-AC-POWERED |
Product Code | FSA |
Date Received | 2020-03-16 |
Model Number | KM560181 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ARJOHUNTLEIGH MAGOG INC. |
Manufacturer Address | 2001 TANGUAY STREET MAGOG, QUEBEC J1X 5Y5 CA J1X 5Y5 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-03-16 |