FDA Adverse Event
Death
Summary report: N
INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER
MDR report key: 252593
·
Received December 6, 1999
Report
- Report Number
- 1527736-1999-06169
- Event Type
- Death
- Date Received
- December 6, 1999
- Date of Event
- November 10, 1999
- Report Date
- November 18, 1999
- Manufacturer
- INDIGO MEDICAL, INC.
- Product Code
- GEX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE SALES REP THAT THE PRODUCT WAS USED IN AN INTERSTITIAL LASER COAGULATION. THE PROCEDURE WENT FINE AND THE PT DID NOT EXPERIENCE ANY COMPLICATIONS. HOWEVER, THE NEXT DAY THE 92-YR OLD MALE PT DEVELOPED SEPSIS AND EXPIRED. THE PHYSICIAN STATED THAT THE PT HAD MULTIPLE HEALTH PROBLEMS. THE PHYSICIAN WAS OUT OF THE OFFICE THIS PAST WEEK AND WAS INFORMED TODAY (11/18/1999) ABOUT THIS INCIDENT; THEREFORE THE REP WAS NOT NOTIFIED UNITL TODAY (11/18/1999).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDIGO FIBEROPTIC TEMPERATURE SENSING FIBER | INDIGO-FIBER | GEX | INDIGO MEDICAL, INC. | NA | M4EP46 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Death |