MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-24 for ROHO? HIGH PROFILE? SINGLE COMPARTMENT CUSHION 1R1112C manufactured by Roho, Inc..
[87179792]
The patient stated he does not check cushion inflation per the safety information in the cushion operation manual and labels. Also, while the customer claimed an injury, roho has not seen medical records confirming this. The cushion was evaluated, but roho was unable to determine if there was a manufacturing defect due to the patches put in place by the customer. The cushion was also being used two years past the warranty period.
Patient Sequence No: 1, Text Type: N, H10
[87179793]
Patient contacted roho and stated that his cushion went flat and it caused a pressure sore that required hospitalization and surgery. The cushion started to go down and he did not realize it because he doesn't routinely perform hand checks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2017-00005 |
| MDR Report Key | 6889224 |
| Report Source | CONSUMER |
| Date Received | 2017-09-24 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-04-01 |
| Date Mfgr Received | 2017-08-24 |
| Device Manufacturer Date | 2013-05-28 |
| Date Added to Maude | 2017-09-24 |
| 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 | JOHN KECK |
| Manufacturer Street | 100 N FLORIDA |
| Manufacturer City | BELLEVILLE IL 62221 |
| Manufacturer Country | US |
| Manufacturer Postal | 62221 |
| Manufacturer Phone | 8008513449 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | 1501 S. 7TH ST. |
| Manufacturer City | BELLEVILLE IL 62223 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 62223 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROHO? HIGH PROFILE? SINGLE COMPARTMENT CUSHION |
| Generic Name | CUSHION, FLOTATION, PRODUCT CODE KIC |
| Product Code | KIC |
| Date Received | 2017-09-24 |
| Returned To Mfg | 2017-09-21 |
| Model Number | 1R1112C |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROHO, INC. |
| Manufacturer Address | 100 N. FLORIDA AVE. BELLEVILLE IL 62221 US 62221 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-09-24 |