MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-26 for STRYKER PERFORMANCE SERIES STERNUM BLADE(30.5 X 1MM) 6207097101 manufactured by Stryker Instruments-kalamazoo.
Report Number | 0001811755-2019-03087 |
MDR Report Key | 9123743 |
Date Received | 2019-09-26 |
Date of Report | 2019-11-15 |
Date of Event | 2019-09-11 |
Date Mfgr Received | 2019-11-15 |
Date Added to Maude | 2019-09-26 |
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. UNA BARRY |
Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
Manufacturer City | CARRIGTWOHILL NA |
Manufacturer Postal | NA |
Manufacturer Phone | 214532900 |
Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
Manufacturer City | CARRIGTWOHILL NA |
Manufacturer Postal Code | NA |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | STRYKER PERFORMANCE SERIES STERNUM BLADE(30.5 X 1MM) |
Generic Name | BLADE, SAW, SURGICAL, CARDIOVASCULAR |
Product Code | DWH |
Date Received | 2019-09-26 |
Catalog Number | 6207097101 |
Lot Number | UNKNOWN |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-09-26 |