MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-20 for 19.5MM X 86 X 1.27MM (050 INCH) OSCILLATOR BLADE 00507118100 manufactured by Conmed Corporation.
Report Number | 1017294-2020-00081 |
MDR Report Key | 9734375 |
Report Source | COMPANY REPRESENTATIVE,DISTRI |
Date Received | 2020-02-20 |
Date of Report | 2020-03-25 |
Date of Event | 2020-01-16 |
Date Mfgr Received | 2020-03-12 |
Device Manufacturer Date | 2019-07-30 |
Date Added to Maude | 2020-02-20 |
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 | MELANIE LANNON |
Manufacturer Street | 11311 CONCEPT BOULEVARD |
Manufacturer City | LARGO, FL |
Manufacturer Country | US |
Manufacturer Phone | 3995209 |
Manufacturer G1 | CONMED CORPORATION |
Manufacturer Street | 11311 CONCEPT BOULEVARD |
Manufacturer City | LARGO, FL |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | 19.5MM X 86 X 1.27MM (050 INCH) OSCILLATOR BLADE |
Generic Name | SAW BLADE |
Product Code | GFA |
Date Received | 2020-02-20 |
Returned To Mfg | 2020-03-02 |
Catalog Number | 00507118100 |
Lot Number | 1039924 |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CONMED CORPORATION |
Manufacturer Address | 11311 CONCEPT BOULEVARD LARGO, FL US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-02-20 |