Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UMANO MEDICAL INC.; MEDICAL BED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UMANO MEDICAL INC.; MEDICAL BED Back to Search Results
Model Number FM500
Medical Device Problem Code Solder Joint Fracture (2324)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/14/2021
Type of Reportable Event Malfunction
Event or Problem Description
Distributor contacted technical service of manufacturer to report about a bed with a broken foot siderail arm.He mentioned that the welding on the end of the link arm was found defective.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Common Device Name
MEDICAL BED
Manufacturer (Section D)
UMANO MEDICAL INC.
230 boulevard nilus-leclerc
l'islet, quebec G0R 2 C0
CA  G0R 2C0
Manufacturer (Section G)
UMANO MEDICAL INC.
230 boulevard nilus-leclerc
l'islet, quebec 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 Key12759119
Report Number3009591865-2021-00022
Device Sequence Number3133515
Product Code FNL
UDI-Device Identifier00670482000463
UDI-Public010067048200046311210209
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Y
Reporter Type Manufacturer
Report Source Distributor
Initial Reporter Occupation 505
Type of Report Initial
Report Date (Section B) 11/04/2021
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? Yes
Operator of Device Other
Device Model NumberFM500
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/14/2021
Initial Report FDA Received Date11/07/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured02/09/2021
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient SexUnknown
-
-