MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-03-04 for ANCHOR PLATE SIZE 46 114010046 manufactured by Depuy Orthopaedics Inc Us.
Report Number | 1818910-2020-06876 |
MDR Report Key | 9788492 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
Date Received | 2020-03-04 |
Date of Report | 2020-02-14 |
Date of Event | 2020-02-10 |
Date Mfgr Received | 2020-02-14 |
Device Manufacturer Date | 2018-05-31 |
Date Added to Maude | 2020-03-04 |
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 | 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 IRELAND - 9616671 |
Manufacturer Street | LOUGHBEG RINGASKIDDY CO. |
Manufacturer City | CORK |
Manufacturer Country | EI |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ANCHOR PLATE SIZE 46 |
Generic Name | SHOULDER HUMERAL STEM ACCESSORY |
Product Code | HSD |
Date Received | 2020-03-04 |
Catalog Number | 114010046 |
Lot Number | 8775324 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DEPUY ORTHOPAEDICS INC US |
Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-04 |