FDA Adverse Event
Injury
Summary report: N
PEEL-AWAY DENNY SHEATH INTRODUCER SET
MDR report key: 1982717
·
Received February 4, 2011
Report
- Report Number
- 1820334-2011-00060
- Event Type
- Injury
- Date Received
- February 4, 2011
- Report Date
- January 7, 2011
- Manufacturer
- COOK, INC.
- Product Code
- DYB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PATIENT OUTCOME WAS NOT PROVIDED BY THE REPORTER. DEVICE BREAKAGE IS NOT LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE DEVICE BROKE OFF IN THE PATIENT. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED BY THE REPORTER. PATIENT OUTCOME IS UNKNOWN AS NOT PROVIDED BY THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEEL-AWAY DENNY SHEATH INTRODUCER SET | DYB INTRODUCER SET | DYB | COOK, INC. | NA | 2556826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |