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 2019-10-17 for TC LEXER SCISS NARR CVD 165MM BC283R manufactured by Aesculap Ag.
Report Number | 9610612-2019-00719 |
MDR Report Key | 9202925 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-10-17 |
Date of Report | 2019-10-17 |
Date of Event | 2019-09-09 |
Date Mfgr Received | 2019-09-20 |
Date Added to Maude | 2019-10-17 |
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 KERSTIN ROTHWEILER |
Manufacturer Street | PO BOX 40 |
Manufacturer City | TUTTLINGEN, 78501 |
Manufacturer Country | GM |
Manufacturer Postal | 78501 |
Manufacturer G1 | AESCULAP AG |
Manufacturer Street | PO BOX 40 |
Manufacturer City | TUTTLINGEN, 78501 |
Manufacturer Country | GM |
Manufacturer Postal Code | 78501 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | TC LEXER SCISS NARR CVD 165MM |
Generic Name | GENERAL SURGICAL INSTRUMENTS |
Product Code | LRW |
Date Received | 2019-10-17 |
Returned To Mfg | 2019-09-25 |
Model Number | BC283R |
Catalog Number | BC283R |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | AESCULAP AG |
Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-10-17 |