MAUDE Adverse Event Report: MAXHEALTH CORP. CAREX; STEP N REST RETAIL

Model Number FGA22300 0000

Device Problems Break (1069); Device Issue (2379)

Patient Problems Contusion (1787); Fall (1848)

Event Date 10/31/2016

Event Type  Injury  

Event Description

Consumer fell when sitting on, the unit administering medication via a shot.Wheel fell off and she got hurt.Horribly bruised on right side.Emt's had to come and pick her up.Consumer did not seek medical attention.Bruises are gone.Does not use unit to scoot or have others push her while seated.Only uses to walk with and sit to rest.Consumer uses walker every step she takes.She is (b)(6) and has a three (3) broken bones in her back (not related to this event).She likes the curve on the backrest as she needs this when she sits down.She puts full weight on both sides of the unit as she is walking to help her walk.Walker in caged storage as she just moved.Cannot get item number or serial number at this time.

Event Description

Correcting manufacturer name - it is unknown.

Event Description

Correcting manufacturer name.Serial number is fragmented, ends in (b)(6).Device returned for inspection on 12/12/2016.Findings: upon inspection, the item was found to be used with normal wear.The customer stated that the wheel fell off, and would like to return.The unit was found to have a defective front caster wheel assembly.The caster fork bolt was found to be receded out of the threaded tubing/frame.The bolt & the tubing was found to be slightly stripped.The wheel most likely fell off due to the following reasoning's: ·over tightened bolt.·stripping ·lack of lock tight.·spacer inside caster fork.The units serial number is sticker is practically missing.

Event Description

Correcting supplier, item number.During inspection item was found to be fga22100 0000 which is supplied by (b)(4).

Event Description

Correcting supplier, item number.Initial findings of item being fga221 were incorrect, item is the fga223.

• Brand Name: CAREX
• Type of Device: STEP N REST RETAIL
• Manufacturer (Section D): MAXHEALTH CORP.; 14f, no. 99, section 1; xintai 5th road; xizhi district new taipei city, 22102 ; TW 22102
• MDR Report Key: 6170400
• MDR Text Key: 62247550
• Report Number: 3012316249-2016-00009
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA22300 0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2020
• Distributor Facility Aware Date: 11/17/2016
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 100