N
Patient 1
NO INJURY HAS BEEN REPORTED WITH THIS CONCERN AT THIS TIME. FURTHER FOLLOW-UP WILL BE PERFORMED AS NECESSARY.
MAUDE MDR 6892358
- MDR report key
- 6892358
- Report number
- 1523545-2017-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-08-18
- Date received
- 2017-09-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. MARK BEISMANN
- Address
- 3535 KINGS MILLS DRIVE MASON OH 45040 US
- Phone
- 513-513-5133
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MODEL 4200 PNEUMATIC SERIES STOOLS | MODEL 4246 PNEUMATIC STOOL | RELIANCE MEDICAL PRODUCTS, INC. | HMD | 4200 | SEE SERIAL NUMBER | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-09-25 | 0 | 1. O |
Event Narratives#
D
Patient 1
(B)(6) FROM (B)(6) REPORTED THAT THE STOOL SEAT BROKE. (B)(4) FROM RELIANCE MEDICAL PRODUCTS ASKED THE CUSTOMER HOW THIS HAPPENED AND HE STATED, "I JUST SAT DOWN, LEANED BACK AND THE SEAT SNAPPED." HE HAS SEVERAL (B)(4) STOOLS THAT THEY HAVE PURCHASED FROM RELIANCE MEDICAL PRODUCTS OVER THE YEARS. THE STRANGE THING IS THAT THE PERSON INVOLVED WITH THIS EVENT IS NOT A VERY LARGE MALE, APPROXIMATELY (B)(6) POUNDS. THE INDIVIDUAL INVOLVED WAS NOT HURT DUE TO THIS CONCERN.