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: TEOXANE SA TEOXANE; TEOSYAL RHA 4
  • 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
 

TEOXANE SA TEOXANE; TEOSYAL RHA 4 Back to Search Results
Model Number NOT APPLICABLE
Device Problem Unintended Ejection (1234)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The product was not returned and therefore could not be retested.This type of issue is likely to be caused by the wrong assembly of the luer lock to the syringe.A guide of good assembly practices is available in our product's instruction for use.
 
Event Description
The event happened outside the u.S., in (b)(6).According to the received information, the practitioner experienced a cannula ejection when mounting the cannula onto the syringe.No patient outcome was reported.This event is reported considered the risk of serious a serious injury who can happen if this incident becomes recurrent.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TEOXANE
Type of Device
TEOSYAL RHA 4
Manufacturer (Section D)
TEOXANE SA
rue de lyon, 105
geneva, CH-12 03
SZ  CH-1203
Manufacturer Contact
nicolas caill
rue de lyon, 105
geneva, CH-12-03
SZ   CH-1203
MDR Report Key8027386
MDR Text Key127404127
Report Number3005975625-2018-00011
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P170002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2019
Device Model NumberNOT APPLICABLE
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberTPUL-174015B
Was Device Available for Evaluation? No
Date Manufacturer Received07/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-