MAUDE Adverse Event Report: CAREX; TRANSPORT CHAIR

Model Number FGA22600 0000

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2020

Event Type  Injury  

Event Description

Plaintiff is informed and believes, and thereon alleges, that at all relevant times in or about august 15, 2020 said product was designed, manufactured, advertised, marketed and sold by defendants carex, ghh (god's helping hand) ministries, does 1 to 99, inclusive, and roes 1 to 99, inclusive, and each of them, for purchase and use by members of the general public in the state of california.Subsequently, on or about october 18, 2020, plaintiff was injured while using the subject product designed, manufactured, packaged, advertised, distributed and placed into the stream of commerce for sale in the state of california by defendants, and each of them.Plaintiff is informed and believes, and thereon alleges, that at all relevant times in or about october 18, 2020 said product identified as a "wheelchair", sold to plaintiff by defendants, was dangerous and defective in its design and manufacturing, and unfit for any purpose, or was in such an unsafe condition when sold by defendants to plaintiff, that it constituted a dangerous and defective product.Plaintiff is informed and believes, and thereon alleges, that the misconduct of defendants, and each of them, is the proximate cause of all damages to plaintiff herein alleged.The full nature and extent of plaintiff's injuries and damages are not presently known, and plaintiff shall seek leave to amend to include further and additional damages at a later time.As a direct and proximate result of the misconduct of the defendants, and each of them, plaintiff was seriously injured in health, strength and activity, sustaining injury to the body and shock and injury to the nervous system and person, all of which said injuries have caused and continue to cause plaintiff great physical, mental and nervous pain, suffering and anguish, all to plaintiff's general damage in a sum in excess of the minimal jurisdictional requirements of this court to be determined at some future date, according to law.As a further direct and proximate result of the misconduct of the defendants, and each of them, plaintiff was required to, and did, employ physicians, surgeons and other health care practitioners to examine, treat and care for him, and did incur medical and incidental expenses.Plaintiff is further informed and believes, and hereon alleges, that said design of the subject product was horribly defective and incredibly dangerous.The intended design of the product called created a situation where the subject product was unsteady, unstable and unsafe.The subject product was and is prone to collapse and/or tipping or falling over.As such the product was known by defendants to cause serious harm to intended users, including severe injury and death.As a result, the subject product as intentionally designed was unsafe for its intended use under any circumstances.

Event Description

Received item number, upc number, and pictures.Pic 1 shows a "carex caring for you" label and a upc barcode label showing "made in china".Pic 2 shows a "carex caring for you" label and a upc barcode label showing "a226-00 made in china".Pic 3 shows the bottom of the device, stickers visible, wheels worn, left wheel lock is bent outward, right wheel lock is straight.Once zooming in a sticker is visible on the left cross brace reading "series #(b)(6)".Pic 4 is a front view of the device, back bars are folded down and right (facing) hand grip is broken off halfway (missing), seat is extremely worn/dirty/bleach marks and stitching appears stretched, front hand screw sections are rusted around the bolts, front casters very worn.Pic 5 is a back view of the device showing the "carex caring for you" logo on the back upholstery, back is folded down.Pic 6 is again of the "carex caring for you" sticker and upc barcode sticker.Pic 7 is again of the upc barcode sticker.Pic 8 is a close-up of the sticker showing "a226-00 made in china" sticker.Pic 9 is again of the upc barcode sticker.

Event Description

Update: while the complaint is short on facts, what can be readily determined is that claims to have purchased a wheelchair manufactured by compass from helping hand on (b)(6) 2020.On (b)(6) 2020, suffered an injury while using the wheelchair.Paragraph 28 of the complaint implies that the wheelchair tipped over with in it, as alleges, "the subject product was and is prone to collapse and/or tipping or falling over" no further information is provided in the complaint.

Event Description

Update: while sitting on and using the subject product, the hinge/locking mechanism of the subject product broke, causing plaintiff to fall backwards and suffering serious and permanent injures.The collapse of the subject product, was not caused in any part by plaintiff's conduct while sitting on and/or using the subject product.On or about (b)(6), 2020, plaintiff was injured while using the subject product designed, manufactured, packaged, advertised, distributed and placed into the stream of commerce for sale in the state of california by defendants, and each of them.While sitting on and using the subject product, part of the subject product collapsed/broke, causing plaintiff to fall, strike her head resulting in serious and permanent injures.The collapse/break of the subject product, was not caused in any part by plaintiff's conduct while sitting on the subject product.

• Brand Name: CAREX
• Type of Device: TRANSPORT CHAIR
• MDR Report Key: 16466630
• MDR Text Key: 310500595
• Report Number: 3012316249-2023-00001
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FGA22600 0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2023
• Distributor Facility Aware Date: 09/19/2023
• Device Age: 29 YR
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other