MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-04-21 for ROHO? STANDARD CUSHION COVER COV-MTO manufactured by Roho, Inc..
[43207060]
The suspect product was not available for evaluation. During conversations with the complainant, the following was noted: the customer does not follow the cushion adjustment instructions in the operation manual (see attached cushion adjustment instructions from the cushion and cover operation manual, revision 4/21/2015). Instead, while he is off the cushion, he pushes both fists into the cushion and as long as he doesn't touch the base, he uses the cushion. This method could result in the cushion being over-inflated and effect his stability while on the cushion and cover. Based on communications with the complainant, roho has determined that the cushion cover did not malfunction in any way. Production logs for the cover were reviewed and show that it was made per the documented requirements. See the attached productions log review file. During conversations with the complainant, roho representatives attempted to obtain the more precise manufacturer's information associated with the manual wheelchair in question. The customer was unable to provide this information.
Patient Sequence No: 1, Text Type: N, H10
[43207061]
The customer stated he was going slowly down a sidewalk and hit a curb cut (where the curb meets the street) and slid out of the chair. He stated that he usually does a wheelie to get down or up curb cuts, but this time he was talking with a friend and didn't notice the curb in time to do the wheelie. Also, he stated the curb cut was a little steeper than a normal curb cut. After moving over the curb cut, the customer stated he was unable to maintain his position. He stopped his chair, but he kept sliding. It was a slow slide off of the chair. He also stated that he slipped twice that day, but got caught by someone one of the times. The customer stated he got cut up and rolled to the left and out of the chair. When he hit the ground, he fractured his tibia, broke off a small part of his patella and damaged ligament. He was seen by his physician, who stated surgery was not needed. He needs to keep his leg up and ice it a few times a day for several weeks. He also switched to a high protein diet. He is strapping his legs in now because he is at high risk of an additional injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2016-00001 |
| MDR Report Key | 5594127 |
| Report Source | CONSUMER |
| Date Received | 2016-04-21 |
| Date of Report | 2016-04-15 |
| Date of Event | 2016-01-02 |
| Date Mfgr Received | 2016-03-24 |
| Date Added to Maude | 2016-04-21 |
| 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 | 1501 S. 74TH ST. |
| Manufacturer City | BELLEVILLE IL 62223 |
| Manufacturer Country | US |
| Manufacturer Postal | 62223 |
| Manufacturer Phone | 8003562990 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | 100 N. FLORIDA AVE. |
| Manufacturer City | BELLEVILLE IL 62221 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 62221 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROHO? STANDARD CUSHION COVER |
| Generic Name | ACCESSORIES, WHEELCHAIR |
| Product Code | KNO |
| Date Received | 2016-04-21 |
| Model Number | COV-MTO |
| Lot Number | 20151209 |
| 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 | 100 N. FLORIDA AVE. BELLEVILLE IL 62221 US 62221 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-21 |