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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; ELECTRIC POSITIONING CHAIR
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PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; ELECTRIC POSITIONING CHAIR Back to Search Results
Model Number LC525IPW
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Pressure Sore/Ulcer (2326)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Lumbar pillow was ordered but was not received by the customer.Lumbar pillow was then sent directly to the customer.The lc525ipw is designed to assist a user from a standing to a seated position as well as from a seated position to a standing position.Therefore, it is unlikely that the missing lumbar pillow caused or contributed to the alleged bed sores.
 
Event or Problem Description
Consumer alleges the lumbar pillow wasn't with the lift chair when it was delivered.Consumer also alleges that the missing lumbar pillow caused her to get 3 bed sores.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Common Device Name
ELECTRIC POSITIONING CHAIR
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
401 york ave
duryea PA 18642
MDR Report Key8297827
Report Number2530130-2019-00005
Device Sequence Number2463775
Product Code INO
UDI-Device Identifier00606509400114
UDI-Public00606509400114
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K091578
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/28/2019
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
Operator of Device Lay User/Patient
Device Model NumberLC525IPW
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/16/2019
Initial Report FDA Received Date02/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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