N
Patient 1
DEVICE NOT RETURNED FOR EVALUATION.
MAUDE MDR 5816768
- MDR report key
- 5816768
- Report number
- 2182780-2016-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-05-30
- Date received
- 2016-07-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. KAYCEE NICHOLS
- Address
- 6753 ENGLE ROAD MIDDLEBURG HEIGHTS OH 44130 US
- Phone
- 800-800-8009
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ULTRA PILL SPLLITER | PILL SPLITTER | COMPASS HEALTH BRANDS | OHY | 70068 | 70068 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-07-22 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE END-USER SUSTAINED AN INJURY ON MEMORIAL DAY ((B)(6) 2016) FROM THE ULTRA PILL SPLITTER. AS SHE WAS REMOVING THE PILL, THE BLADE GUARD SPRING BROKE AND CAME DOWN ON HER INDEX FINGER. BECAUSE THE CUT WAS SO DEEP AND WOULDN'T STOP BLEEDING, SHE HAD TO GO TO THE ER FOR SUTURES, A TETANUS SHOT AND ANTIBIOTICS FOR TWO WEEKS. SHE INDICATED THAT, HAD THE BLADE NOT HIT PART OF HER FINGER NAIL, SHE WOULD HAVE LOST THE END OF HER FINGER. THE PILL SPLITTER WAS USED TO CUT A SMALL PAIN RELIEVER (ROUND ONE), AND WAS ONLY USED FOR PAIN RELIEVERS. SHE HAD THE PRODUCT FOR 3 MONTHS, AND HAD NEVER PUT IT IN WATER. SHE INDICATED THAT SHE HAD NEVER CLEANED THE PRODUCT, SHE ONLY TURNS THE PRODUCT UPSIDE DOWN TO GET THE DUST OUT OF THE TRAY. FINALLY, AFTER 4-5 WEEKS, THE DEEP CUT HAD HEALED, BUT SHE DOES NOT HAVE ANY FEELING IN THE END OF HER FINGER.