D
Patient 1
END USER'S WIFE ADVISED WHEN HER HUSBAND WAS WALKING IN THE KITCHEN THE (B)(4) CRUTCHES WOBBLED AND HE FELL. NO APPARENT INJURIES, NO MEDICAL ATTENTION SOUGHT.
MAUDE MDR 4408039
- MDR report key
- 4408039
- Report number
- 1531186-2015-00188
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-09-23
- Date received
- 2015-01-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 306
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Report source
- D
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | QUICK CHANGE CRUTCH ADULT 9153618192 | TIPS AND PADS, CANE, CRUTCH AND WALKE | HEALTHPLUS | INP | 8115-A | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-01-12 | 0 | 1. O |
Event Narratives#
N
Patient 1
INITIAL MFG REPORT # 1531186-2014-04910 WAS SUBMITTED TO THE FDA ON 10/17/2014. ADDITIONAL INFORMATION HAS BEEN OBTAINED FOR THE REPORT BUT DUE TO INVACARE'S UPDATED TRACKWISE SYSTEM A NORMAL FOLLOW-UP REPORT COULD NOT BE TRANSMITTED THROUGH NORMAL CHANNELS. (B)(4).