• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

  • 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
 

CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3072
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Swelling (2091); Reaction (2414)
Event Date 12/16/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). It has been communicated that the device and/or lot information is not available for evaluation. Without the device and/or lot information, it is not possible for codman to conduct a proper investigation. If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time, this complaint is considered closed. Device not available.
 
Event Description
Patient presented in the er with a bubbly, pus rash of red and purple color on the face and head. Left eye swollen shut. No reaction on torso. No reaction reported prior to discharge from original implant. Patient reports allergy to morphine, sulpha and vancomycin. However, vancomycin was administered in the hospital with no reaction noted. To resolve issue, consulted dermatology trying to identify origin, introducing bactiseal catheter to dermis to see if there is a reaction. Not explanted as of yet. (b)(6) 2015 per rep: "the patient was seen in the er and not sure if she was admitted or not, but i would assume so. So, yes, there is an adverse event. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
ch-2400 le locle
SZ
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key5350275
MDR Text Key35244916
Report Number1226348-2016-10027
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK003322
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number82-3072
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/07/2016 Patient Sequence Number: 1
-
-