FDA Adverse Event
Injury
Summary report: N
ASTROGLIDE
MDR report key: 18479678
·
Received January 9, 2024
Report
- Report Number
- 0002025771-2023-07004
- Event Type
- Injury
- Date Received
- January 9, 2024
- Date of Event
- September 26, 2023
- Report Date
- September 26, 2023
- Manufacturer
- COMBE INC
- Product Code
- NUC
- PMA / PMN Number
- K935299
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
USER ALLEGED ONE OF OUR LUBRICANTS CAUSED THEM TO CATCH ON FIRE. FROM THE USER: "YOUR PRODUCT IS FLAMMABLE!!! I'M SURE YOU WERE AWARE OF THIS, BUT ELECTED NOT TO DISCLOSE IT, NOR PLACE WARNING LABELS ON THE UNIT PACKAGING OR THE BOTTLE. THIS WILLFUL NEGLECT ON YOUR PART HAS CAUSED ME PHYSICAL HARM, INJURY AND PERHAPS PERMANENT SCARRING. I HAVE ALSO SUFFERED EMOTIONAL DISTRESS, EMBARRASSMENT AND THE LOSS OF CONSORTIUM WITH MY PARTNER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553720 | ASTROGLIDE | PERSONAL LUBRICANT | NUC | COMBE INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Prefer Not To Disclose | Disability |