MAUDE Adverse Event Report: AMERICAN NATIONAL MFG, INC. 252 MARIAH CIRCLE, CA MATTRESS, FLOTATION THERAPHY, NON-POWERED; MATTRESS, FLOTATION THERAPY, NON-POWERED

Device Problem Collapse (1099)

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

Event Type  malfunction  

Event Description

Complained of dip in mattress.Replacement issued.Swapped it for a ma65 upon request.No injury alleged.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS, FLOTATION THERAPHY, NON-POWERED
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): AMERICAN NATIONAL MFG, INC. 252 MARIAH CIRCLE, CA
• MDR Report Key: 17534724
• MDR Text Key: 321409605
• Report Number: MW5141624
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2015

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1