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: STERILMED, INC.
  • 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
 

STERILMED, INC. Back to Search Results
Model Number APPCTR03
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2013
Event Type  malfunction  
Event Description
It was reported that during a laparoscopic bilateral tubal ligation after inserting the device and pulling out the obturator, the top broke off and co2 leaked.Another device was used to complete the procedure.There was no pt injury.
 
Manufacturer Narrative
Final device investigation found that the device was returned with the sleeve seal cap broken off.The obturator was in good visual condition.The sleeve could not be pressure tested due to its condition.The device history record was reviewed and no discrepancies were noted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NA
Manufacturer (Section D)
STERILMED, INC.
maple grove MN
Manufacturer Contact
tracia schrater
11400 73rd ave north
maple grove, MN 55369
7634883211
MDR Report Key3747896
MDR Text Key4463664
Report Number2134070-2014-00019
Device Sequence Number1
Product Code NLM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/06/2014
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
Device Operator Health Professional
Device Expiration Date08/01/2014
Device Model NumberAPPCTR03
Device Catalogue NumberCTR03
Device Lot Number1682299
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/14/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/06/2014
Initial Date FDA Received01/22/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-