MAUDE Adverse Event Report: UMANO MEDICAL INC.; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2022

Event Type  Injury  

Manufacturer Narrative

At the moment of this initial medical device report, manufacturer is still working with the establishment to get information about the sentinel event.Due to a potential severity associated with a sentinel event, the manufacturer initiate this mdr even though it doesn't have all the required information for the moment.

Event Description

Manufacturer was notified of a potential sentinel event.The customer alleged that one of our product have contributed to this event.No further information is now available about the circumstances of the event, the patient's condition and the product involved.

Event Description

Manufacturer was notified of a potential sentinel event.The customer alleged that one of our product have contributed to this event.

Manufacturer Narrative

On september 23, 2022, a umano representative received an email from the initial reporter, alleging a potential sentinel event involving one of our beds.On the same day, we promptly responded to the email by requesting further information about the circumstances of the event, including any consequences and the product involved.However, we did not receive any details.On september 28, 2022, a umano representative sent an email to the initial reporter, emphasizing that our company takes such reports very seriously and he requested to either schedule a visit to the facility or conduct an interview by phone to better understand the issue.However, the initial reporter stated that the requested information was considered federally protected internal patient safety information and therefore not disclosable.Due to the potential severity associated with a sentinel event, the manufacturer initiated an mdr on october 3rd, 2022, even though it did not have all the required information.After, multiple attempts were also made by phone to follow up with the initial reporter, but no response was received.Finally, on february 7, 2023, the umano representative was able to speak with the assistant manager of the healthcare facility who confirmed that there were no issues or complaints related to our beds.Moreover, there is no evidence or any other communication to suggest that there was an incident involving one of our products at this facility.

• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: saoussen gammoudi ; 230 boulevard nilus-leclerc; l'islet, qc G0R 2-C0 ; CA G0R 2C0
• MDR Report Key: 15650293
• MDR Text Key: 302179421
• Report Number: 3009591865-2022-00027
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other