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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERITS HEALTH PRODUCTS CO.,LTD MERITS; VISION SPORT

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MERITS HEALTH PRODUCTS CO.,LTD MERITS; VISION SPORT Back to Search Results
Model Number P326A
Device Problem Fracture (1260)
Patient Problem Fall (1848)
Event Date 03/02/2021
Event Type  malfunction  
Event Description
Patient was at her neighbor's house and as she left her driveway that had slight incline the seat post of the chair sheared off causing her to fall out of the chair with the seat on top of her causing injury.She did not want to go to the hospital due to covid.No ambulance was called, her neighbor just brought her into the house.She have a dr's appointment 3/4 8:00 am.
 
Event Description
Patient was at her neighbor's house and as she left her driveway that had slight incline the seat post of the chair sheared off causing her to fall out of the chair with the seat on top of her causing injury.She did not want to go to the hospital due to covid.No ambulance was called, her neighbor just brought her into the house.She have a dr's appointment (b)(6) 8:00 am.
 
Manufacturer Narrative
There was a typing error in the model name of the device in the original submission file (b)(4).The model number for the device is p326a.
 
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Brand Name
MERITS
Type of Device
VISION SPORT
Manufacturer (Section D)
MERITS HEALTH PRODUCTS CO.,LTD
no. 18. jingke rd,tpmt park,
nantun district
taichung city, 40852
CH  40852
MDR Report Key11637771
MDR Text Key247024143
Report Number9680333-2021-00002
Device Sequence Number1
Product Code ITI
UDI-Device Identifier04714379292541
UDI-Public04714379292541
Combination Product (y/n)N
PMA/PMN Number
K012802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberP326A
Initial Date Manufacturer Received 03/11/2021
Initial Date FDA Received04/08/2021
Supplement Dates Manufacturer Received03/11/2021
Supplement Dates FDA Received05/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
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