MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for LOCKING SCREWDRIVER BODY 2307-92-003 230792003 manufactured by Depuy France Sas - 3003895575.
Report Number | 1818910-2020-09633 |
MDR Report Key | 9900546 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-30 |
Date of Report | 2020-03-16 |
Date of Event | 2020-03-16 |
Date Mfgr Received | 2020-03-30 |
Device Manufacturer Date | 2017-10-02 |
Date Added to Maude | 2020-03-30 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. KARA DITTY-BOVARD |
Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
Manufacturer City | WARSAW IN 465810988 |
Manufacturer Country | US |
Manufacturer Postal | 465810988 |
Manufacturer Phone | 6107428552 |
Manufacturer G1 | DEPUY ORTHOPAEDICS INC US |
Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
Manufacturer City | WARSAW IN 465810988 |
Manufacturer Country | US |
Manufacturer Postal Code | 465810988 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | LOCKING SCREWDRIVER BODY |
Generic Name | EXTREMITY INSTRUMENTS : SCREWDRIVERS |
Product Code | HXX |
Date Received | 2020-03-30 |
Returned To Mfg | 2020-03-30 |
Model Number | 2307-92-003 |
Catalog Number | 230792003 |
Lot Number | 5294423 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DEPUY FRANCE SAS - 3003895575 |
Manufacturer Address | 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-30 |