MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-22 for SAGITTAL BLADE 2108218000 manufactured by Stryker Ireland Ltd..
[1438092]
It was reported that the blade edges had perforated the sterile packaging. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[8597003]
There were a number of items associated with this complaint. It can be confirmed from visual inspection that product packaging is damaged. Other complaints have been received reporting similar events. A secondary polybag has been introduced into the packaging configuration of these products to address this issue.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 9616696-2010-00176 |
MDR Report Key | 1625711 |
Report Source | 07 |
Date Received | 2010-02-22 |
Date of Report | 2009-07-22 |
Date of Event | 2009-07-20 |
Date Mfgr Received | 2009-07-22 |
Date Added to Maude | 2011-02-02 |
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 | 0 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | UNA |
Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
Manufacturer City | CARRIGTWOHILL, CORK |
Manufacturer Country | EI |
Manufacturer Phone | 214532963 |
Manufacturer G1 | STRYKER IRELAND LTD. |
Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
Manufacturer City | CARRIGTWOHILL, CORK |
Manufacturer Country | EI |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SAGITTAL BLADE |
Generic Name | SAW BLADES AND ACCESSORIES |
Product Code | DWH |
Date Received | 2010-02-22 |
Catalog Number | 2108218000 |
Lot Number | 09106027 |
Device Expiration Date | 2014-04-01 |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STRYKER IRELAND LTD. |
Manufacturer Address | CARRIGTWOHILL, CORK EI |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2010-02-22 |