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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; CHAIR, POSITIONING, ELECTRIC

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PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; CHAIR, POSITIONING, ELECTRIC Back to Search Results
Model Number PLR975M
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Abrasion (1689)
Event Type  Injury  
Manufacturer Narrative
The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.
 
Event Description
Ider alleges consumer alleges fabric is bleeding onto his clothes and skin allegedly causing him to get a rash.
 
Event Description
Provider alleges consumer alleges fabric is bleeding onto his clothes and skin allegedly causing him to get a rash.
 
Manufacturer Narrative
Customer misuse.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Type of Device
CHAIR, POSITIONING, ELECTRIC
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
401 york ave
duryea PA 18642
Manufacturer (Section G)
N/A
n/a
n/a
n/a
Manufacturer Contact
kelly livingston
401 york ave
duryea, PA 18642
5706024056
MDR Report Key16148076
MDR Text Key307193873
Report Number2530130-2023-00006
Device Sequence Number1
Product Code INO
UDI-Device Identifier00606509400930
UDI-Public00606509400930
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPLR975M
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received01/06/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/23/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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