FDA Adverse Event
Death
Summary report: N
INDIGO 1 CM FIBER
MDR report key: 183273
·
Received August 19, 1998
Report
- Report Number
- 1527736-1998-02520
- Event Type
- Death
- Date Received
- August 19, 1998
- Date of Event
- June 15, 1998
- Report Date
- July 7, 1998
- Manufacturer
- INDIGO MEDICAL, INC.
- Product Code
- GEX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
08/21/1998 CLARIFICATION: DESCRIPTION OF DIFFUSER ERROR CODE WAS NOT A REPORTABLE EVENT. 07/07/1998 ADVERSE EVENT OCCURRED DURING REOPERATION. ORIGINAL MEDWATCH SHOULD HAVE SHOWN "CONTINUE TO PAGE 3 OF 3 FOR ADDITIONAL DESCRIPTION OF EVENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDIGO 1 CM FIBER | LASER-SURGERY DEVICE | GEX | INDIGO MEDICAL, INC. | NA | K48R6T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Death |