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

MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

  • 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 INC. GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number PROC2
Device Problem Material Erosion (1214)
Patient Problems Erosion (1750); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2015 through (b)(6) 2015 supplemental 13 - attachment: [(b)(6) 2015 otp supplemental 13. Xlsx].
 
Manufacturer Narrative
Ethicon mdr summary reporting exemption (b)(4). Reporting period june 1, 2015 through july 31, 2015.
 
Manufacturer Narrative
Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2015 through (b)(6) 2015 supplemental 14 - attachment: [(b)(6) 2015 otp supplemental 14. Xlsx].
 
Manufacturer Narrative
Ethicon mdr summary reporting exemption (b)(4). Reporting period june 1, 2015 through july 31, 2015.
 
Manufacturer Narrative
Ethicon mdr summary reporting exemption (b)(4). Reporting period june 1, 2015 through july 31, 2015.
 
Manufacturer Narrative
Ethicon mdr summary reporting exemption (b)(4). Reporting period june 1, 2015 through july 31, 2015.
 
Manufacturer Narrative
Ethicon mdr summary reporting exemption (b)(4). Reporting period june 1, 2015 through july 31, 2015.
 
Manufacturer Narrative
Date sent to fda: 12/27/2018. Ethicon mdr summary reporting exemption e2013037. Reporting period june 1, 2015 through july 31, 2015.
 
Manufacturer Narrative
Date sent to fda: 2/12/2019. Ethicon mdr summary reporting exemption e2013037. Reporting period june 1, 2015 through july 31, 2015.
 
Manufacturer Narrative
Date sent to fda: 12/20/2019. Ethicon mdr summary reporting exemption e2013037. Reporting period june 1, 2015 through july 31, 2015.
 
Manufacturer Narrative
Date sent to fda: 04/24/2019. Ethicon mdr summary reporting exemption e2013037. Reporting period june 1, 2015 through july 31, 2015.
 
Manufacturer Narrative
(b)(4) date sent to the fda: 8/25/2015. (b)(4) conclusion code: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. (b)(4) total number of events: 272. Gynecare prolift +m anterior pelvic floor repair system - 15, gynecare prolift +m pelvic floor repair system - 6, gynecare prolift +m posterior pelvic floor repair system - 14, gynecare prolift +m total pelvic floor repair system - 14, gynecare prolift anterior pelvic floor repair system - 48, gynecare prolift pelvic floor repair system - 35, gynecare prolift posterior pelvic floor repair system - 36, gynecare prolift total pelvic floor repair system - 74, gynecare prosima pelvic floor repair system - 29, gynecare prosima pelvic floor repair systems.
 
Event Description
It was reported that a patient underwent a gynecological procedure on (b)(6) 2010 and mesh was implanted. The patient experienced pain, erosion of internal bodily tissue and other injuries following the procedure and has undergone multiple surgeries and revisionary procedures. No additional information was provided.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4). Reporting period (b)(4) 2015.
 
Manufacturer Narrative
(b)(4). Reporting period (b)(4) 2015.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4). Reporting period (b)(6) 2015.
 
Manufacturer Narrative
Ethicon mdr summary reporting exemption (b)(4). Reporting period (b)(4) 2015.
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEM
Type of DeviceMESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20 2000 neuchatel
neuchatel
SZ
Manufacturer Contact
mary szaro
route 22 west po box 151
somerville, NJ 08876
9082183464
MDR Report Key5032177
MDR Text Key103972384
Report Number2210968-2015-05624
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2012
Device Catalogue NumberPROC2
Device Lot Number3408157
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/25/2010
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: 08/26/2015 Patient Sequence Number: 1
-
-