FDA Adverse Event
Other
Summary report: N
*
MDR report key: 564161
·
Received December 10, 2004
Report
- Report Number
- 564161
- Event Type
- Other
- Date Received
- December 10, 2004
- Date of Event
- December 9, 2004
- Report Date
- December 10, 2004
- Manufacturer
- STERIS CORPORATION
- Product Code
- FYD
- Report Source
- User Facility report
- Reporter Location
- WA, US
Narratives
Description of Event or Problem · 1
STERILE PACKAGING IS FALLING APART, SECOND REPORT OF THIS TYPE WITH THE SAME PRODUCT, DIFFERENT LOT NUMBER.FOLLOW-UP WITH SITE REVEALS THAT TYVEK SEAL IS INTACT, BUT WHEN PACKAGE IS OPENED, A CLEAN BREAK DOES NOT OCCUR - PLASTIC HAS A JAGGED EDGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | TUBING, SURGICAL SMOKE EVACUATION | FYD | STERIS CORPORATION | * | 44-000361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |