| 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 | IPR | 8115-A | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-10-14 | 0 | 1. O |
Patient 1
END USER'S WIFE ADVISED HER HUSBAND WAS WALKING AND THE PLASTIC PIECE THAT HOLDS THE ADJUST BAR SLIPPED DOWN ON CRUTCHES AND CAUSED THEM TO BE WOBBLY. END USER FELL DOWN THE STAIRS ONTO THE FLOOR. NO APPARENT INJURIES AND NO MEDICAL ATTENTION SOUGHT. END USER IS A RECENT AMPUTEE AND GOES TO PHYSICAL THERAPY WHO IS MADE AWARE WHEN HE FALLS. THEY ARE UNSURE OF MODEL OF CRUTCH, BUT THINKS IT IS THE ADJUST.
Patient 1
END USER'S WIFE ADVISED HER HUSBAND WAS WALKING AND THE PLASTIC PIECE THAT HOLDS THE ADJUST BAR SLIPPED DOWN ON CRUTCHES AND CAUSED THEM TO BE WOBBLY. END USER FELL DOWN THE STAIRS ONTO THE FLOOR. NO APPARENT INJURIES AND NO MEDICAL ATTENTION SOUGHT. END USER IS A RECENT AMPUTEE AND GOES TO PHYSICAL THERAPY WHO IS MADE AWARE WHEN HE FALLS. THEY ARE UNSURE OF MODEL OF CRUTCH, BUT THINKS IT IS THE ADJUST.
Patient 1
(B)(4) 2014 -- INITIAL MFG REPORT # 1525712-2014-06966 WAS SUBMITTED TO THE FDA ON 10/14/2014 AS A MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN OBTAINED. WITH THE KNOWLEDGE OF THE ACTUAL MANUFACTURER THIS IS NOW AN IMPORTER REPORT, NOT A MANUFACTURER, THEREFORE, THE CORRECT FDA REGISTRATION # IS (B)(4).