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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.) SW PULSATE VCR MATTRESS; SIZEWISE PULSATE VERSACARE MATTRESS
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RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.) SW PULSATE VCR MATTRESS; SIZEWISE PULSATE VERSACARE MATTRESS Back to Search Results
Model Number APULV
Medical Device Problem Code Inflation Problem (1310)
Health Effect - Clinical Code Pressure Sore/Ulcer (2326)
Date of Event 04/12/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The patient incurred a hospital-acquired pressure injury on a sizewise versacare pulsate mattress replacement.Nursing staff noticed a deflated air cell in the patient's sacral area which they identified as the possible cause for the wound.
 
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Brand Name
SW PULSATE VCR MATTRESS
Common Device Name
SIZEWISE PULSATE VERSACARE MATTRESS
Manufacturer (Section D)
RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.)
206 jefferson st.
ellis KS 67637
MDR Report Key12359558
Report Number0001931307-2021-00002
Device Sequence Number3937330
Product Code FNL
UDI-Device Identifier00845699000722
UDI-Public00845699000722
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Nurse
Remedial Action Repair
Type of Report Initial
Report Date (Section B) 04/12/2021
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 NumberAPULV
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/12/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/12/2021
Initial Report FDA Received Date08/24/2021
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; Required Intervention;
Patient Weight75
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