• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD/DAVOL, SUBSIDARY OF CR BARD KUGEL HERNIA MESH SMALL OVAL 8CM BY 11.76 CM/3" 4.6

  • 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
 

BARD/DAVOL, SUBSIDARY OF CR BARD KUGEL HERNIA MESH SMALL OVAL 8CM BY 11.76 CM/3" 4.6 Back to Search Results
Catalog Number 0010101
Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913); Material Deformation (2976)
Patient Problems Cyst(s) (1800); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Sepsis (2067); Vomiting (2144); Burning Sensation (2146); Hernia (2240); Hernia (2240); Anxiety (2328); Reaction (2414); Reaction (2414)
Event Date 02/24/2009
Event Type  Injury  
Event Description
The kugel mesh failed within days of surgery.Surgeon (b)(6).Procedure done at (b)(6).Reported it to the surgeon who thought it was my sperm cord but it was the hernia after i heard the device fall inside me.I immediately went back to the surgeon a few times.I was told it was my sperm cord that was so long and it was actually hernia.My body had sepsis several times.And also many infections after sex that were not std related.Also, severe reaction in which my body had severe anaphylactic reactions.I have to have an open repair and now additional hernias from not being able to exercise.I also taste blood in my mouth after attempting to exercise.My name is (b)(6).
 
Event Description
Additional information received from reporter 04/05/2017 (mw5068856) - patient had left inguinal hernia repair with kugel hernia mesh.One day post operative, patient heard and experienced a pop that sounded like a guitar string.Patient states that post ct scan, the mesh appears bunched up causing intestinal pain.There is also a cyst on the side of his kidney.Patient has had sepsis once and anaphylaxis twice.On long road trips, patient has become severely ill twice.The first time he was ill for over a month.The second road trip caused emesis every 1/2 hour.He also has had bouts of strep throat post intercourse.He has linked intercourse with becoming ill.He has experienced a burning sensation and pain in the pubic area 4-5 days post sexual activity.He has had well over 12 infections.Patient states that when he attempts to exercise, he taste blood in his mouth and has gone to the e.R.For this.Patient's hernia is currently the size of a nickel or quarter and has never completely gone away.He believes that his bladder has herniated out.Patient states that initially, the surgeon believed that the hernia was his sperm cord.He experiences pain upon exertion accompanied with an elevated blood pressure.He believes that the use of an infrared sauna to detox has helped his recovery.He has scheduled explantation and cancelled it due to anxiety.He is currently exploring alternative methods of treatment.Patient has also stated that he does not believe his issues were caused by the physician, but is due to the defective mesh product.
 
Event Description
The kugel mesh failed within days of surgery.Surgeon (b)(6).Procedure done at (b)(6).Reported it to the surgeon who thought it was my sperm cord but it was the hernia after i heard the device fall inside me.I immediately went back to the surgeon a few times.I was told it was my sperm cord that was so long and it was actually hernia.My body had sepsis several times.And also many infections after sex that were not std related.Also, severe reaction in which my body had severe anaphylactic reactions.I have to have an open repair and now additional hernias from not being able to exercise.I also taste blood in my mouth after attempting to exercise.My name is (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
KUGEL HERNIA MESH SMALL OVAL 8CM BY 11.76 CM/3" 4.6
Type of Device
KUGEL HERNIA MESH
Manufacturer (Section D)
BARD/DAVOL, SUBSIDARY OF CR BARD
MDR Report Key6456283
MDR Text Key71743119
Report NumberMW5068856
Device Sequence Number0
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 04/05/2017
2 Devices were Involved in the Event: 1   2  
2 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0010101
Device Lot NumberHURJ1114
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Life Threatening; Other; Required Intervention; Disability;
Patient Weight86
-
-