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

Model Number COV-MTO

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

Patient Problems Bone Fracture(s) (1870); Damage to Ligament(s) (1952)

Event Date 01/02/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ROHO® STANDARD CUSHION COVER
• Type of Device: ACCESSORIES, WHEELCHAIR
• Manufacturer (Section D): ROHO, INC.; 100 n. florida ave.; belleville IL 62221
• Manufacturer (Section G): ROHO, INC.; 100 n. florida ave.; belleville IL 62221
• Manufacturer Contact: robin gergen ; 1501 s. 74th st.; belleville, IL 62223 ; 8003562990
• MDR Report Key: 5594127
• MDR Text Key: 43207060
• Report Number: 1419507-2016-00001
• 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
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: COV-MTO
• Device Lot Number: 20151209
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ROHO LOW PROFILE SINGLE COMPARTMENT CUSHION
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 75