• 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. MALLA PROLENE SMALL 6CM X 11CM 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. MALLA PROLENE SMALL 6CM X 11CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMS3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Neuropathy (1983); Pain (1994); Hypoesthesia (2352); Ambulation Difficulties (2544)
Event Date 01/01/2012
Event Type  Injury  
Manufacturer Narrative

(b)(4). If the device or further details are received at a later date a supplemental medwatch will be sent.

 
Event Description

It was reported by the patient that they underwent hernia procedure in (b)(6) 1998 and mesh was implanted to repair small reducible inguinal hernia. Following the procedure, the patient reported it has caused the following symptoms, that started after having a hysterectomy in 2012: ¿neuropathy; rashes; sinus; fatigue; feeling poisoned; eyes, dry, blurred vision; gums, receding, taste, dry mouth; sore throat; chest pain. Heartburn sternum pain; pains; numbness; groin, legs, sharp pains - electric/brambles; joint stiffness; bladder, weird sensations; tells lies; leaks; numbness over wound site; brain fog; memory loss; walking/clumsy; hot sweats; hands - dropping things; bowels, prolapse; dyspareunia¿. The patient reported that ¿these have all developed at different rates over the years. The degree of effect of each symptom can vary from day to day. It's taken a few years to get to the cause of it all, but i have just seen a consultant who said that the symptoms i have are in line with the complications of mesh and that it needs removing. ¿ no additional information was provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMALLA PROLENE SMALL 6CM X 11CM
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
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8334109
MDR Text Key135995594
Report Number2210968-2019-78777
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 CONSUMER,FOREIGN,OTHER
Reporter Occupation
Type of Report Initial
Report Date 01/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMS3
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/12/2019 Patient Sequence Number: 1
-
-