MAUDE Adverse Event Report: R82 A/S CROCODILE

Model Number 86852

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/13/2019

Event Type  malfunction  

Event Description

Text from incident report received from (b)(6): phone from occupational therapist; user have had an incident with the device.The device is mostly used at pools, usually he uses crutches.Incident were reported to the municipal physiotherapist on (b)(6) 2019, so incident has most likely happened the day before.Physio and occupational have been with users' guardians on (b)(6) 2019, to clarify what happened.Occupational therapist heard about the incident (b)(6) 2019.- orally.Event: when using / transferring in the pool area, the user would rest on the chair of the walking chair.He has done this many times before.This time, the seat gave way, and the user fell and was sent to a hospital where there was found a fracture in the leg.Municipal health and technical center have examined the product and believe the construction looks something bad and that it locks poorly.When they put on force/weight on the seat, it gives way.

Manufacturer Narrative

Nav technician has inspected the device with following conclusion: i have now carried out technical examination of product.No technical error found with product.User weight is up to 45kg on this product.The seat is tested up to 60kg.The seat is stress tested / pushed when the locking screw is 3mm from the end of the slit / groove: then the seat / stop points can give in and can cause the user to fall in the floor, which is what i suspect in this case.Manufacturer conclusion: incident caused by incorrect unfolding of device by user.

Event Description

Text from incident report received from national medicines agency: phone from occupational therapist; user have had an incident with the device.The device is mostly used at pools, usually he uses crutches.Incident were reported to the municipal physiotherapist on october 14, 19, so incident has most likely happened the day before.Physio and occupational have been with users' guardians on october 24, 19, to clarify what happened.Occupational therapist heard about the incident 21.10.19.- orally.Event: when using / transferring in the pool area, the user would rest on the chair of the walking chair.He has done this many times before.This time, the seat gave way, and the user fell and was sent to a hospital where there was found a fracture in the leg.Municipal health and technical center have examined the product and believe the construction looks something bad and that it locks poorly.When they put on force/weight on the seat, it gives way.

• Brand Name: CROCODILE
• Type of Device: CROCODILE
• Manufacturer (Section D): R82 A/S; parallelvej 3; gedved, 8751 ; DA 8751
• MDR Report Key: 9389690
• MDR Text Key: 191311521
• Report Number: 3001657382-2019-00019
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

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: 86852
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/28/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Weight: 50