MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2009-02-05 for TERUMO OVERPRESSURE SAFETY VALVE LN130B manufactured by *.
Report Number | 1124841-2009-00002 |
MDR Report Key | 1310646 |
Report Source | 00,05,06 |
Date Received | 2009-02-05 |
Date Mfgr Received | 2009-02-02 |
Device Manufacturer Date | 2008-06-01 |
Date Added to Maude | 2009-02-12 |
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 | 0 |
Manufacturer Contact | SUE MCQUERREY |
Manufacturer Street | 125 BLUE BALL RD. |
Manufacturer City | ELKTON MD 21921 |
Manufacturer Country | US |
Manufacturer Postal | 21921 |
Manufacturer Phone | 8002837866 |
Manufacturer G1 | TERUMO CARDIOVASCULAR SYSTEMS CORP |
Manufacturer Street | 125 BLUE BALL RD. |
Manufacturer City | ELKTON MD 21921 |
Manufacturer Country | US |
Manufacturer Postal Code | 21921 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | TERUMO OVERPRESSURE SAFETY VALVE |
Generic Name | NONE |
Product Code | MNJ |
Date Received | 2009-02-05 |
Returned To Mfg | 2009-01-23 |
Model Number | NA |
Catalog Number | LN130B |
Lot Number | KG16 |
ID Number | * |
Device Expiration Date | 2011-05-31 |
Device Availability | R |
Device Age | 6 MO |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | * |
Manufacturer Address | * * * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2009-02-05 |