| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ROHO | WHEELCHAIR CUSHION | ROHO, INC. | KIC | QS912C | * | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-08-29 | 0 | 1. H; 2. R |
Patient 1
THE USER STATES THAT THEY REQUIRE SURGERY AND HOSPITALIZATION. HOWEVER, ROHO HAS NOT RECEIVED MEDICAL RECORDS TO CONFIRM THIS. THE DEVICE HAS NOT YET BEEN EVALUATED TO DETERMINE IF THE ISSUE WAS A USE ERROR OR RESULTED FROM A DEFECT IN MATERIAL. IF WE RECEIVE ANY FOLLOW UP INFORMATION OR AN EVALUATION IS MADE, AN ADDITIONAL REPORT WILL BE SUBMITTED.
Patient 1
A DEALER NOTIFIED US THAT THERE WAS AN INJURY CLAIM ON ONE OF OUR CUSHIONS. THEY STATED THAT THE USER SAT ON HER NEW CUSHION FOR A WHOLE DAY WHILE IT WAS DEFLATED WITHOUT NOTICING IT WAS FLAT. THE DEALER WAS NOT SURE IF THE USER OPENED THE VALVE AND LET THE AIR OUT ACCIDENTLY OR IF THE PRODUCT WAS DEFECTIVE SOMEHOW. SHE IS A VERY ACTIVE USER WITH NO SENSATION. SHE HAS USED OUR PRODUCTS BEFORE IN THE PAST. HOWEVER, THIS WAS THE FIRST DAY OF USING THIS NEW CUSHION. SHE'S BEEN A PARAPLEGIC FOR 23 YEARS. THE PRODUCT WAS DELIVERED THE DAY PRIOR AND WAS SET UP BY THE DEALER. THE NEXT DAY THE USER TRANSFERRED INTO IT AND ASSUMED EVERYTHING WAS STILL WORKING PROPERLY. IT IS UNCLEAR IF THE MANUFACTURER'S ADJUSTMENT INSTRUCTIONS WERE FOLLOWED. SHE SAT ON IT FOR 8-12 HOURS THAT DAY. SHE DID NOT DISCOVER THAT SHE WAS WOUNDED UNTIL THAT NIGHT WHEN SHE GOT IN BED. WOUND IS ON THE LEFT ISCHIAL AND WENT ALL THE WAY TO THE BONE. A FLAP SURGERY IS SCHEDULED FOR MONDAY. SHE WILL BE IN THE HOSPITAL FOR 4 WEEKS POST SURGERY AND THEN DISCHARGED TO RECOVER AT HOME.