MAUDE Adverse Event Report: UMANO MEDICAL INC OOK SNOW; MEDICAL BED

Model Number FL36

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Skull Fracture (2077); Hip Fracture (2349)

Event Date 03/28/2021

Event Type  Injury  

Event Description

Manufacturer was contacted by user site for reporting of a patient fall following an alleged undetected bed exiting.

• Brand Name: OOK SNOW
• Type of Device: MEDICAL BED
• Manufacturer (Section D): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, qc G0R 2 C0; CA G0R 2C0
• Manufacturer (Section G): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, qc G0R 2 C0; CA G0R 2C0
• Manufacturer Contact: maude thibault ; 230 boulevard nilus-leclerc; l'islet, qc G0R 2-C0 ; CA G0R 2C0
• MDR Report Key: 11785752
• MDR Text Key: 251942949
• Report Number: 3009591865-2021-00006
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES 85592
• Patient Sequence Number: 1
• Patient Outcome(s): Other