MAUDE Adverse Event Report: UNKNOWN ROLLITE ROLLATOR 9153637242; WALKER, MECHANICAL

Model Number 65100

Device Problems Unintended Collision (1429); Positioning Problem (3009)

Patient Problems Death (1802); Sepsis (2067); Tissue Damage (2104); Ventilator Dependent (2395)

Event Date 06/13/2015

Event Type  Death  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

Letter received from lawyer, stating the following: please be advised that i represent the personal representative of the estate of end user, deceased.Lawyer is stating that end user slipped near her bed on (b)(4) 2015, and her right tibia came into contact with an exposed screw on the lower portion of her walker manufactured by invacare.End user was treated by emergency team and later at the hospital wound care center.Unfortunately on (b)(6) 2015 she became septic, was intubated, put on ventilator and subsequently passed away on (b)(6) 2015.

• Brand Name: ROLLITE ROLLATOR 9153637242
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5293376
• MDR Text Key: 33397658
• Report Number: 1525712-2015-05766
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/07/2015

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: 65100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/14/2015
• 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): Death