FDA Adverse Event
Other
Summary report: N
TEN20 CONDUCTIVE PASTE
MDR report key: 2595965
·
Received November 26, 2008
Report
- Report Number
- 1718791-2008-00003
- Event Type
- Other
- Date Received
- November 26, 2008
- Date of Event
- November 5, 2008
- Report Date
- November 25, 2008
- Manufacturer
- D.O. WEAVER AND CO.
- Product Code
- GYB
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
LIMITED INVESTIGATION. USER OFFICE GOT A CALL FROM PT, BUT DID NOT DO ANY F/U WITH PT REGARDING IRRITATION AND INJURY. UNUSUAL EVENT. LAB MADE AN INITIAL CALL TO US REGARDING INFO, BUT HAD NOT FOLLOWED UP WITH PT AFTER THE FIRST DAY AND HAS NOT HEARD BACK FROM THE PT.
Description of Event or Problem · 1
FEMALE PT EXPERIENCED SWELLING AND IRRITATION IN ONE EYE AFTER A SLEEP STUDY WAS PERFORMED. IT IS ASSUMED THAT TEN20 CONDUCTIVE PAST GOT INTO THE PT'S EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEN20 CONDUCTIVE PASTE | CONDUCTIVE PASTE | GYB | D.O. WEAVER AND CO. | 10-20 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |