FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 2008336
·
Received February 16, 2011
Report
- Report Number
- 2936485-2011-00100
- Event Type
- Injury
- Date Received
- February 16, 2011
- Date of Event
- January 25, 2011
- Report Date
- February 2, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- EQH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE HAVE BEEN 3 PATIENTS WITH FULL THICKNESS BURNS FROM LIGHTCABLES AT 2 DIFFERENT HOSPITAL SITES. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | LIGHTCABLE | EQH | STRYKER ENDOSCOPY SAN JOSE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |