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: ULRICH GMBH & CO. KG SMALL VBR; CAGE
  • 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
 

ULRICH GMBH & CO. KG SMALL VBR; CAGE Back to Search Results
Model Number CS 2250-12-16-6
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Codes Pain (1994); Discomfort (2330)
Date of Event 02/28/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Ulrich medical gmbh (manufacturer) is submitting this report for both ulrich medical gmbh and ulrich medical usa (importer) exemption # e2014011.
 
Event or Problem Description
Patient complained she sustained permanent physical injuries as a result of her surgery.Limited information was provided and a company representative is working to get more information on the case from the hospital/surgeon.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SMALL VBR
Common Device Name
CAGE
Manufacturer (Section D)
ULRICH GMBH & CO. KG
buchbrunnenweg 12
ulm, 89081
GM  89081
MDR Report Key7382078
Report Number9612420-2018-00004
Device Sequence Number11119410
Product Code MQP
UDI-Device Identifier04052536009206
UDI-Public4052536009206
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
K012254
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/29/2018
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? No
Operator of Device No Information
Device Model NumberCS 2250-12-16-6
Device Catalogue NumberCS 2250-12-16-6
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/08/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/08/2018
Initial Report FDA Received Date03/29/2018
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 Other;
Patient Age50 YR
-
-