MAUDE Adverse Event Report: CURBELL MEDICAL PRODUCTS, INC. STR MAT-4X30X76-2T-STD FOAM-BW-CAL117-PC; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number SM-43076-2T-SFBW117-PC

Device Problem Degraded (1153)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Event Description

Mattresses purchased from curbell began to break down on the stryker 1115 big wheel prime series stretcher where the head rest hinges at.The break down created voids in the mattress that became uncomfortable and offered no support in that region.At the time this happened the mattress were only three months old.Sales representative was looking into the issue.

• Brand Name: STR MAT-4X30X76-2T-STD FOAM-BW-CAL117-PC
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): CURBELL MEDICAL PRODUCTS, INC.; 20 centre dr; orchard park NY 14127
• MDR Report Key: 15671497
• MDR Text Key: 302420375
• Report Number: 15671497
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2022,09/27/2022

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 Model Number: SM-43076-2T-SFBW117-PC
• Device Catalogue Number: 23201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1