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: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC
  • 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. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Migration (4003)
Patient Problems Erosion (1750); Pain (1994); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Ethicon mdr summary reporting exemption (b)(4).Reporting period december 1, 2018 through january 31, 2019 (b)(4).Total number of events ¿ 18.Proceed multi-layer mesh - 0.Prolene polypropylene mesh - 14.Prolene soft polypropylene mesh - 4 ultrapro mesh - 0.Vicryl polyglactin 910 mesh ¿ 0.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and the mesh was implanted.It was reported that the patient experienced pain and erosion and underwent revisionary procedure.No additional information is available.
 
Manufacturer Narrative
Ethicon mdr summary reporting exemption e2013037.Reporting period december 1, 2018 through january 31, 2019.Supplemental 01.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8320031
MDR Text Key135514572
Report Number2210968-2019-70458
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received04/24/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-