MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-08-30 for ROHO? HIGH PROFILE? SINGLE COMPARTMENT CUSHION 1R1011C manufactured by Roho, Inc..
[156136323]
Roho, inc was notified of an alleged injury on (b)(6) 2019 and an investigation was initiated. Since the initial notification, several attempts have been made to contact the customer including; a mailed letter and nine phone calls. No responses were received following any attempt, and an email address was not provided by the customer. The report of an injury allegation has been documented; however, we are unable to access medical records or reach the customer for confirmation. At initial contact, the end user stated that a piece of their inflation valve was lodged inside of their inflation pump. Due to this, the end user mentioned that they were unable to inflate their cushion for 5 days, during which, their care representative was not available. Upon the care representative's return, it was alleged that the end user's skin was beginning to breakdown due to them using a deflated cushion for the previous 5 days. A request was made by the manufacturer that the cushion along with the pump be returned, due to the inflation valve being designed too large to fit completely into the inflation pump. The customer was sent a replacement cushion, but at this time, the original cushion and pump have not been returned. If additional information is received, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[156136324]
Per end user and their care representative- the end user has been on a flat cushion for 5 days and "his bottom is starting to breakdown".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2019-00004 |
| MDR Report Key | 8950803 |
| Report Source | CONSUMER |
| Date Received | 2019-08-30 |
| Date of Report | 2019-08-29 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-08-01 |
| Device Manufacturer Date | 2018-12-12 |
| Date Added to Maude | 2019-08-30 |
| 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 | MRS. ROBIN GERGEN |
| Manufacturer Street | 1501 S. 74TH STREET |
| Manufacturer City | BELLEVILLE IL 62223 |
| Manufacturer Country | US |
| Manufacturer Postal | 62223 |
| Manufacturer Phone | 8008513449 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | 1501 S. 74TH STREET |
| 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 | WHEELCHAIR CUSHION |
| Product Code | KIC |
| Date Received | 2019-08-30 |
| Model Number | 1R1011C |
| 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 STREET BELLEVILLE IL 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-30 |