MAUDE Adverse Event Report: INVAMEX DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 9650-4

Device Problem Component Falling (1105)

Patient Problems Fall (1848); Injury (2348)

Event Type  No Answer Provided  

Event Description

Caregiver, alleges that both of the pail holders fell out and the end uer fell.When asked how she fell, end use was unaware.She states the seat is still intact.She states she hurt her hip.She alleges it is her right side.No bruising or bleeding.She says this happened the day prior.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3967889
• MDR Text Key: 4629077
• Report Number: 9616091-2014-01367
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial
• Report Date: 06/25/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9650-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 99
• Patient Weight: 73