MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-16 for ROHO? HIGH PROFILE? SINGLE COMPARTMENT CUSHION 1R1011H-CA-SR manufactured by Roho, Inc..
[82818183]
The customer and his wife stated they did not believe the cushion was leaking or otherwise malfunctioning, but indicated that he slipped on the cushion while using it in the car. They did not state he fell off the cushion. The customer's wife indicated that she repositioned her husband so he was back in the original location on the cushion when he had slipped. They both stated they felt the cushion was inflated properly (did not have too much or too little air). He did, however, state that the cushion felt uncomfortable. The customer stated he used the cushion for about 4-6 weeks before they noticed the injury. They stated they received a replacement cushion after the va did pressure mapping. The replacement cushion had a gel insert and a rigid foam base. Roho, inc. Does not manufacture cushions will gel inserts. The customer did not know the brand name or model of the replacement cushion. His wife indicated that the replacement cushion was painful due to the rigid foam and was not being used. She made cushions herself and they believe those cushions are working. While the customer made the claim of a serious injury, roho has not seen medical records to confirm this. Roho sent the customer a (b)(6) label for the cushion and smart check to be returned for evaluation, but they have not arrived yet. If they are returned, a follow up report will be submitted with the evaluation results. Because the cushion has not yet been returned, roho review the device history record for serial (b)(4) and found that it was made according to the specification in the device master record.
Patient Sequence No: 1, Text Type: N, H10
[82818184]
The customer stated that he and his wife were driving and he was using his cushion in the car. He kept sliding on the cushion and his wife had to slide him back on the cushion. His wife stated that the cushion cells cause irritation when she place him back on the cushion. The customer continued to use the cushion until they saw a hole between his buttocks and thigh, at which time he was seen by the va medical center. He said the hole/wound almost went down to the bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2017-00002 |
| MDR Report Key | 6798214 |
| Report Source | CONSUMER |
| Date Received | 2017-08-16 |
| Date of Report | 2017-08-16 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2017-07-17 |
| Device Manufacturer Date | 2016-02-25 |
| Date Added to Maude | 2017-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ROBIN GERGEN |
| Manufacturer Street | 100 N. FLORIDA AVE. |
| Manufacturer City | BELLEVILLE IL 62221 |
| Manufacturer Country | US |
| Manufacturer Postal | 62221 |
| Manufacturer Phone | 8008513449 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | 1501 S. 74TH ST. |
| Manufacturer City | BELLEVILLE IL 62223 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 62223 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROHO? HIGH PROFILE? SINGLE COMPARTMENT CUSHION |
| Generic Name | SENSOR READY WHEECHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2017-08-16 |
| Model Number | 1R1011H-CA-SR |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROHO, INC. |
| Manufacturer Address | 1501 S. 74TH ST. BELLEVILLE IL 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-16 |