FDA Adverse Event
Other
Summary report: N
FLEXIBLE LIGHT HANDLE COVER
MDR report key: 3035995
·
Received February 22, 2013
Report
- Report Number
- 1836161-2013-00082
- Event Type
- Other
- Date Received
- February 22, 2013
- Date of Event
- August 7, 2012
- Report Date
- February 22, 2012
- Manufacturer
- ASPEN SURGICAL PRODUCTS, INC.
- Product Code
- FTA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DUE TO A RECENT FDA INSPECTION THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVAL. REVIEW OF PHOTOS SHOWED THAT THE LIGHT HANDLE COVER WAS NOT BEING USED WITH THE ASPEN ADAPTOR. THE COVER IS DESIGNED SPECIFICALLY FOR THE ASPEN ADAPTOR.
Description of Event or Problem · 1
LIGHT HANDLE COVER FELL OFF DURING OPEN HEART SURGERY CASE ONTO PT. DR WILL NO LONGER ALLOW COVERS TO BE USED IN ANY CASES. WHEN IT WAS REMOVED FROM THE PACKAGE IT WAS WRINKLED AND MISSHAPED, IT SEEMS TO NOT SECURELY FIT THE LIGHT HANDLE - THIS IS A SECOND INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78505 | FLEXIBLE LIGHT HANDLE COVER | LIGHT HANDLE COVER | FTA | ASPEN SURGICAL PRODUCTS, INC. | 10700-*-*-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |