MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-08-11 for ROHO HIGH PROFILE CUSHION manufactured by Roho, Inc..
[23924315]
Roho was not made aware of this injury until approx. 4 years after it took place. The nurse that contacted roho is working for an attorney and has not personally evaluated the end user. She did not give roho any patient identifying information due to hippa, therefore, roho does not have any means of contacting the end user or evaluating the cushion that was in use at the time of the car accident. Based on the information that was provided by the nurse, there may have been several different factors contributing to the end user's injury, including but not limited to improper inflation of her cushion, extended periods of sitting under pressure relief, and a car accident. If additional information is obtained, a supplement report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[23924316]
Roho was contacted on (b)(6) 2015 by a nurse consultant working for an attorney. All of our information on the patient and her injury came from two phone conversations with this nurse. The nurse stated the following during the initial call: the patient is a c5-c6 quadriplegic. The patient was driving her car and got hit on the right side, then hit a tree. The impact was at 25-30 mph. The patient claims that the valve on her roho cushion broke and her cushion went flat. There is no information on how the valve was broken or if any action was taken to repair it or to get a replacement cushion. The patient developed a wound that she blames on the flat cushion. She was later hospitalized for the wound and underwent surgery and bed rest. The patient's chart shows that there was a smaller wound prior to the car accident, but that it got bigger after the accident. The chart also shows that there was undermining and tunneling under the surface of the wound. The patient would drive to and from florida twice a year, a 30 hour drive each way, and did not get out of the car during the trips. The patient's chart also indicated that she had been told numerous times to make sure her cushion was inflated properly and not under-inflated like she tends to have it. A therapist had pressure mapped the patient and the record shows the use of a high profile roho cushion. The nurse did not give any additional information on the cushion model, manufacture date, how it was used, etc. She was also unable to give any patient identifying information. The attorney that the nurse is working for is trying to determine if the wound was caused by the accident or if it was caused by the cushion going flat. The nurse stated she thinks the wound is most likely a result of traveling for long hours and deciding to sit during travel without performing a pressure relief. In the second conversation with the nurse, she provided the following additional information: the car accident happened on (b)(6) 2011. At the time of the accident, the patient went to the emergency room and was discharged with no injuries. On (b)(6) 2011, the patient had surgery on the wound and was placed on bed rest to allow it to heal. In (b)(6) 2011, the patient traveled to (b)(6) from (b)(6). It wasn't until the spring of 2012 that the patient claimed that the valve on the roho cushion broke at the time of the car accident
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419507-2015-00002 |
| MDR Report Key | 5022220 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-08-11 |
| Date of Report | 2015-08-11 |
| Date of Event | 2011-07-30 |
| Date Mfgr Received | 2015-07-14 |
| Date Added to Maude | 2015-08-21 |
| 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 | 100 NORTH FLORIDA AVE. |
| Manufacturer City | BELLEVILLE IL 622215429 |
| Manufacturer Country | US |
| Manufacturer Postal | 622215429 |
| Manufacturer Phone | 8003562990 |
| Manufacturer G1 | ROHO, INC. |
| Manufacturer Street | 100 NORTH FLORIDA AVE. |
| Manufacturer City | BELLEVILLE IL 622215429 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 622215429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROHO HIGH PROFILE CUSHION |
| Product Code | KIC |
| Date Received | 2015-08-11 |
| 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 NORTH FLORIDA AVE. BELLEVILLE IL 622215429 US 622215429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-11 |