MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-11 for UNKNOWN MICROSENSOR XXX-MICROSENSOR manufactured by Integra Lifesciences Switzerland Sar.
Report Number | 1226348-2019-00515 |
MDR Report Key | 9304862 |
Date Received | 2019-11-11 |
Date of Report | 2019-10-15 |
Date of Event | 2019-10-15 |
Date Mfgr Received | 2019-10-15 |
Date Added to Maude | 2019-11-11 |
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 | 3 |
Manufacturer Contact | MRS. VIVIAN NELSON |
Manufacturer Street | 325 PARAMOUNT DRIVE |
Manufacturer City | RAYNHAM MA 02767 |
Manufacturer Country | US |
Manufacturer Postal | 02767 |
Manufacturer G1 | INTEGRA LIFESCIENCES SWITZERLAND SAR |
Manufacturer Street | RUE GIRARDET 29 CH-2400 |
Manufacturer City | LE LOCLE |
Manufacturer Country | SZ |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | UNKNOWN MICROSENSOR |
Generic Name | MICROSENSOR |
Product Code | GWM |
Date Received | 2019-11-11 |
Catalog Number | XXX-MICROSENSOR |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTEGRA LIFESCIENCES SWITZERLAND SAR |
Manufacturer Address | RUE GIRARDET 29 RUE GIRARDET 29 LE LOCLE SZ |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-11 |