• 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 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 MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMH
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. To date, the device has not been returned. If the device or further details are received at a later date, a supplemental medwatch will be sent. (b)(4). Total number of events ¿ (b)(4); physiomesh - (b)(4); proceed multi-layer laminate mesh unknown ¿ (b)(4); proceed multi-layer laminate mesh ¿ (b)(4); prolene polypropylene mesh - (b)(4); prolene polypropylene mesh unknown product - (b)(4); ultrapro mesh - (b)(4); vicryl polyglactin 910 mesh ¿ (b)(4).

 
Event Description

Wcq received an e-mail from the ethicon risk manager team stating the following: it was reported that the patient underwent a gynecological surgical procedure to treat pop & sui on (b)(6) 2006 and prolene mesh was implanted. It was reported that the patient experienced undisclosed injuries. No additional information was provided.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Date sent to the fda: 04/20/2017. Ethicon mdr summary reporting exemption (b)(4). Reporting period october 1, 2016 through november 30, 2016.

 
Manufacturer Narrative

Date sent to fda: (b)(6)/2018. Ethicon mdr summary reporting exemption e2013037. Reporting period october 1, 2016 through november 30, 2016. Supplemental 07 - attachment: [12-31-2016 ftl supplemental 07. Xlsx].

 
Manufacturer Narrative

Date sent to the fda: 06/28/2017 ethicon mdr summary reporting (b)(4) reporting period (b)(6) 2016 supplemental 03 - attachment: [(b)(6) 2016 ftl supplemental 03. Xlsx].

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period october 1, 2016 through november 30, 2016.

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2016 through (b)(6) 2016 supplemental 05 - attachment: [(b)(6) 2016 ftl supplemental 05. Xlsx].

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4) reporting period (b)(6) 2016 through (b)(6) 2016 supplemental 06 - attachment: [(b)(6) 2016 ftl supplemental 06. Xlsx].

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period october 1, 2016 through november 30, 2016.

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period october 1, 2016 through november 30, 2016.

 
Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4). Reporting period october 1, 2016 through november 30, 2016.

 
Manufacturer Narrative

Date sent to fda: (b)(4) 2018. Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2016 through (b)(4) 2016.

 
Manufacturer Narrative

Date sent to fda: 04/24/2019. Ethicon mdr summary reporting exemption e2013037. Reporting period october 1, 2016 through november 30, 2016.

 
Manufacturer Narrative

Date sent to fda: 02/12/2019. Ethicon mdr summary reporting exemption e2013037. Reporting period october 1, 2016 through november 30, 2016.

 
Manufacturer Narrative

Date sent to fda: 12/27/2018. Ethicon mdr summary reporting exemption e2013037. Reporting period october 1, 2016 through november 30, 2016.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROLENE POLYPROPYLENE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key6195818
MDR Text Key63056933
Report Number2210968-2016-13590
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK962530
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 09/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2011
Device Catalogue NumberPMH
Device LOT NumberXDB733
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 Received04/19/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured04/06/2006
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: 12/21/2016 Patient Sequence Number: 1
-
-