MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-22 for ROHO? UNIVERSAL CUSHION COVER UCFR79 manufactured by Roho, Inc..
[112066096]
The customer did not state that the cushion cover malfunctioned. The customer also stated that 23 hours of continual use was not normal use. While the customer reported a serious injury, roho has not seen medical records to confirm the injury. Roho has sent the customer a new cover and included a return label for the cover in use at the time of the injury, so we can evaluate the product. If the cover is returned, roho will submit a follow-up report after it has been evaluated. This report was initially submitted on 11/3/2017. At that time, acknowledgements were received stating that the submission was received. However, after some months now, it has become evident that the submission failed due to a typo in the manufacturer's report number. Instead of "1415709", it should have been "1419507". [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[112066097]
The customer stated he had a pressure ulcer for the first time in 29 years. He stated he received a new cushion cover, dated 2015, and that he noticed the top material of the cover was different from his previous covers when he dropped a cigarette on it and the material did not burn. After roho contacted the customer for additional information, he stated that he had been in the hospital and/or on bed rest for 3 months. He also stated his injury was on his left ischial and had required surgery. He told us he noticed the pressure injury after he sat on the cushion for 23 hours straight, which was not typical use for him. He noticed his bottom and his blue jeans were sweatier than usual after this prolonged, continual use of the cushion and cover and this may have contributed to the injury. He did not think that cushion or cover malfunctioned, but thought that the different cover material did not have the same airflow as the previous material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2017-00006 |
| MDR Report Key | 7630381 |
| Report Source | CONSUMER |
| Date Received | 2018-06-22 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-10-05 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2018-06-22 |
| 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 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? UNIVERSAL CUSHION COVER |
| Generic Name | WHEELCHAIR CUSHION COVER |
| Product Code | KNO |
| Date Received | 2018-06-22 |
| Model Number | UCFR79 |
| Lot Number | 2015 |
| 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 | ROHO, INC. 1501 S. 74TH STREET BELLEVILLE IL 62223 US 62223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-06-22 |