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

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE

  • 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
 

ETHICON ENDO-SURGERY, LLC. PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE Back to Search Results
Catalog Number PPH03
Event Date 05/21/2012
Event Type  Injury  
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROXIMATE PPH PROCEDURE SET
Type of DeviceSTAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo PR 0096 9
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 0096 9
Manufacturer Contact
kathy rice
4545 creek rd
cincinnati , OH 45242-2803
5133373299
MDR Report Key2616896
Report Number3005075853-2012-02827
Device Sequence Number1
Product CodeGDW
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/22/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/14/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPPH03
Device LOT NumberH44T3C
OTHER Device ID NumberBATCH #: H53284
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/18/2012
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/18/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/28/2011
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: 06/14/2012 Patient Sequence Number: 1
-
-