MAUDE Adverse Event Report: GENDRON BED, MANUAL

Device Problem Mechanical Problem (1384)

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

Stryker medical was notified of a potentially reportable complaint involving a product for which stryker is not the original equipment manufacturer of the reported device.The customer alleged a gendron sentinel ii frame, had a patient slide out of the bed between the rails, but was not injured.Please find additional contact information below.(b)(4).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: 17523877
• MDR Text Key: 321384564
• Report Number: MW5130825
• 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: 07/23/2018

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
• Patient Sequence Number: 1