FDA Adverse Event
Injury
Summary report: N
INDURA
MDR report key: 1012337
·
Received February 12, 2008
Report
- Report Number
- 6000030-2008-01204
- Event Type
- Injury
- Date Received
- February 12, 2008
- Date of Event
- August 1, 2006
- Report Date
- August 21, 2006
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED ITCHING AND INCREASED SPASTICITY. A DYE STUDY REVEALED THAT THE CATHETER WAS BLOCKED. THE CATHETER WAS REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | RICE CREEK MANUFACTURING | 8709AA | J11295R67 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |