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 |