MAUDE Adverse Event Report: ROHO, INC. ROHO® UNIVERSAL CUSHION COVER; WHEELCHAIR CUSHION COVER

Model Number UCFR79

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

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)].

Event Description

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.

• Brand Name: ROHO® UNIVERSAL CUSHION COVER
• Type of Device: WHEELCHAIR CUSHION COVER
• Manufacturer (Section D): ROHO, INC.; roho, inc.; 1501 s. 74th street; belleville IL 62223
• Manufacturer (Section G): ROHO, INC.; 1501 s. 74th street; belleville IL 62223
• Manufacturer Contact: robin gergen ; 100 n. florida ave.; belleville, IL 62221 ; 8008513449
• MDR Report Key: 7630381
• MDR Text Key: 112066096
• Report Number: 1419507-2017-00006
• Device Sequence Number: 1
• Product Code: KNO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UCFR79
• Device Lot Number: 2015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ROHO® HIGH PROFILE® SINGLE COMPARTMENT CUSHION
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 54