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
Catalog Number PROMESHUNK
Device Problem Migration (4003)
Patient Problems Erosion (1750); Incontinence (1928); Pain (1994)
Event Type  Injury  
Event Description
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2009 and prolene was implanted concurrently with anterior and posterior colporrhaphy, enterocele repair and cystoscopy due to stress urinary incontinence, cystocele and rectocele.No additional information was provided.
 
Manufacturer Narrative
This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2017-70668, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
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.
1000 route 202
raritan NJ 08869
MDR Report Key12749881
MDR Text Key282338388
Report Number2210968-2021-10768
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
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPROMESHUNK
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/20/2020
Initial Date FDA Received11/03/2021
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
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
-
-