MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2008-05-30 for manufactured by .
Report Number | 8010042-2008-00068 |
MDR Report Key | 1103623 |
Report Source | 01,05,06,08 |
Date Received | 2008-05-30 |
Date Mfgr Received | 2008-05-22 |
Date Added to Maude | 2008-08-12 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 0 |
Reprocessed and Reused Flag | 0 |
Health Professional | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | JAMIE YIEH |
Manufacturer Street | 1140 ROUTE 22 E, STE 202 |
Manufacturer City | BRIDGEWATER NJ 08807 |
Manufacturer Country | US |
Manufacturer Postal | 08807 |
Manufacturer Phone | 9089472311 |
Manufacturer G1 | MAQUET CRITICAL CARE AB |
Manufacturer Street | * |
Manufacturer City | * S-171 54 |
Manufacturer Country | SW |
Manufacturer Postal Code | S-171 54 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Product Code | MOD |
Date Received | 2008-05-30 |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Device Sequence No | 1 |
Device Event Key | 1082877 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2008-05-30 |