MAUDE Adverse Event Report:; ADAPTOR, HYGIENE

Device Problem Bent (1059)

Patient Problems Pain (1994); Shaking/Tremors (2515)

Event Date 01/02/2016

Event Type  malfunction  

Event Description

Patient completed a stand pivot transfer to the left from wheelchair to the shower chair; legs on the shower chair were stable with no bends and chair had no back.Patient sat on the chair and after a few seconds the back right leg of the shower chair started to bend and the shower chair started to slowly tilt posterior and to the right.The therapist grabbed the patient's gait belt and assisted the patient to slowly slide towards the floor.The patient's right lower extremity was kicked out and he did not put any weight on it throughout this slide to the floor.Patient's right buttock slid to the ground first and therapist removed the shower chair so the patient was completely on the ground.Patient stated he was a little shaky and afraid but reported only a slight increase in pain.Therapist assisted patient to transfer from the raised surface they were on to a footstool using the backwards approach and minimal assistance with verbal cues to keep the right lower extremity extended to maintain a non-weight bearing status.Patient was then able to do a backwards approach from the foot stool onto another shower chair with a back and with contact guard assist.Patient then completed a stand pivot transfer to the left from the shower chair to the wheelchair using a front wheeled walker and minimal assistance.

• Brand Name: UNK
• Type of Device: ADAPTOR, HYGIENE
• MDR Report Key: 5700555
• MDR Text Key: 46600363
• Report Number: 5700555
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 64 YR
• Patient Weight: 99