FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

DAVOL, INC. ENDO-FLO LAPAROSCOPIC IRRIG SYS   back to search results
Catalog Number ZPQNO-STK
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Pt found to have retained piece of product in abdomen.

 
Manufacturer Narrative

Unknown product number, numerous calls to facility did not produce info.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameENDO-FLO
Type of DeviceLAPAROSCOPIC IRRIG SYS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DAVOL, INC.
100 sockanossett xrd
cranston RI 02920
Manufacturer (Section D)
DAVOL, INC.
100 sockanossett xrd
cranston RI 02920
Manufacturer (Section G)
DAVOL INC., SUB. C.R. BARD, INC.
100 sockanossett crossroad
cranston RI 02920
Device Event Key59796
MDR Report Key59369
Event Key55799
Report Number1213643-1996-00044
Device Sequence Number1
Product CodeKQT
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/1996
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberZPQNO-STK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Invalid Data
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH