• 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 SOFT MESH 6INX6IN 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 SOFT MESH 6INX6IN MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPMH
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Incontinence (1928)
Event Type  Injury  
Event Description
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and prolene was implanted. It was reported that the patient underwent mesh revisionary procedure on (b)(6) 2014 due to sui and tvt was implanted. No additional information was provided.
 
Manufacturer Narrative
This emdr represents supplemental report # 2210968-2017-30604 for previously submitted mdr number 2210968-2017-30283, subject of a litigation complaint summary exemption no. E2013037. The referenced exemption was revoked effective may 15, 2019. The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www. Fda. Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr. Therefore, this report does not represent a new reportable event. 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. A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROLENE SOFT MESH 6INX6IN
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
00754 PR
Manufacturer Contact
elba bello
1000 route 202
raritan 08869
MDR Report Key12867512
MDR Text Key285823264
Report Number2210968-2021-12025
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2015
Device Model NumberSPMH
Device Catalogue NumberSPMH
Device Lot NumberCAE475
Was Device Available for Evaluation? No
Date Manufacturer Received10/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2010
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: 11/24/2021 Patient Sequence Number: 1
-
-