MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-02-22 for DUAL CUT SAGITTAL BLADE 4111127090 manufactured by Stryker Ireland Ltd..
[1486708]
It was reported that the product packaging was brittle. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[8483609]
There were two 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. An alternative packaging material has been implemented to address this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2010-00185 |
| MDR Report Key | 1625744 |
| Report Source | 06 |
| Date Received | 2010-02-22 |
| Date of Report | 2009-07-29 |
| Date of Event | 2009-07-29 |
| Date Mfgr Received | 2009-07-29 |
| Date Added to Maude | 2010-11-30 |
| 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 BARRY |
| 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 | DUAL CUT SAGITTAL BLADE |
| Generic Name | SAW BLADES AND ACCESSORIES |
| Product Code | DWH |
| Date Received | 2010-02-22 |
| Catalog Number | 4111127090 |
| Lot Number | 05022077 |
| Device Expiration Date | 2010-01-01 |
| 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 |