MAUDE Adverse Event Report: GENDRON BED, MANUAL

Model Number 4748SD

Device Problem Material Integrity Problem (2978)

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

Event Date 07/14/2018

Event Type  malfunction  

Event Description

(b)(6) called in stating bed fell to the floor with pt on, but there are no injuries.Pt is ok, still using equipment.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED, MANUAL
• Type of Device: BED, MANUAL
• Manufacturer (Section D): GENDRON
• MDR Report Key: 17535968
• MDR Text Key: 321475435
• Report Number: MW5142860
• Device Sequence Number: 1
• Product Code: FNJ
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4748SD
• Patient Sequence Number: 1
• Patient Age: 35 YR