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: MMJ, S.A. DE C.V. SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)
  • 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
 

MMJ, S.A. DE C.V. SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR) Back to Search Results
Model Number 86234
Medical Device Problem Code Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/04/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during use of the device, the markings on the tube were rubbing off with normal use.It was indicated that there was no patient injury in this event and patient symptoms or complications associated with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SHILEY
Common Device Name
TUBE, TRACHEAL (W/WO CONNECTOR)
Manufacturer (Section D)
MMJ, S.A. DE C.V.
ave. henequen no 1181 desarrol
ciudad juarez,ci 32590
MX  32590
MDR Report Key7444702
Report Number2936999-2018-00275
Device Sequence Number1124633
Product Code BTR
UDI-Device Identifier10884521212848
UDI-Public10884521212848
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K151381
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 04/19/2018
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
Operator of Device Health Professional
Device Expiration Date02/22/2022
Device Model Number86234
Device Catalogue Number86234
Device Lot Number17B0459JZX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/04/2018
Initial Report FDA Received Date04/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-