MAUDE Adverse Event Report: DOLOMITE RMA-STANDARD PRODUCTS; WALKER, MECHANICA

Model Number NA:SELFCARE

Device Problem Collapse (1099)

Patient Problems Fall (1848); Injury (2348)

Event Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

This report is being filed in an abundance of caution.Invacare (b)(4) received a letter from the end user stating she has extreme back and leg problems requiring her to use her walker for her every movement.The end user stated she was sitting on the seat of her walker.(walkers do not have seats, this implies that the device is a rollator) and the legs folded up slamming her on the concrete sidewalk.She relates that she hit her head and got a ¿hit the size of a baseball.The end user stated that she was unsure of the serial number when asked for it.She relates she had an mri and to be ¿watched by my son for about 10-15 days¿.The end user stated she called a lawyer, but they wanted half of whatever she would receive so she decided to write to invacare directly.The end user was called for more information: she stated that the rollator folded in while pushing it, causing her to fall back and hit her head, she stated that the seat broke at this time.The end user stated she was admitted to the hospital but was unable to remember all of the tests that were performed.The end user requested that any further questions be sent to her via email.A list of questions was emailed to the end user to obtain more details, she has not responded to multiple requests.It is unclear if the end user was sitting on the rollator, sitting on the rollator while self-propelling or standing up pushing the rollator.It is unclear what medical treatment the end user received.It is unclear if the rollator malfunctioned, if the rollator was being used as intended, or if directions for use in the manual were correctly followed.The user manual states: - use seat for stationary seating only.Never sit and push with your feet, do not use as a wheelchair or transport chair.Folding the rollator: 1.Press down the safety catch.2.Pull the seating tube upwards operating position unfold the walker by pressing down on the seating tube until a clicking sound is heard.It is important that the safety catch is locked before the walker is used.Should additional information become available, a supplemental record will be filed.

Event Description

The end user stated in a letter to invacare (b)(4) that she has a dolomite legacy 600 walker that is 1 year old.She stated that she was sitting on the seat and the legs folded up slamming her on the concrete sidewalk.She hit the back of her head giving her a bump the size of a baseball.She received an mri on her head.

Manufacturer Narrative

Received patient information and medical reports as requested.The patient received a ct of the head and cervical spine the findings stated: head: no intracranial hemorrage, mass, or infarct.No acute abnormality is seen.There is an occipital scalp hematoma, but there is no fracture and no evidence of intrarcranial injury.Cervical spine: there is mild reversal of lordosis but there is no fracture and there is no anterolist or retolisthesis.Alignment is otherwise normal.There is no acute abnormality.If more information is received a follow up will be filed.

Event Description

Received patient information along with final reports from the hospital.On (b)(6) 2018, the patient had a head ct and a ct of the spine cervical.

• Brand Name: RMA-STANDARD PRODUCTS
• Type of Device: WALKER, MECHANICA
• Manufacturer (Section D): DOLOMITE; box 200; vaxjovagen 303; dio
• MDR Report Key: 8088595
• MDR Text Key: 127853874
• Report Number: 9615290-2018-00007
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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: NA:SELFCARE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 11/15/2018
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 99