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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GORE 6 GORE SUTURE
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GORE 6 GORE SUTURE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Impaired Healing (2378); Obstruction/Occlusion (2422); Test Result (2695)
Event Date 09/01/2014
Event Type  No Answer Provided  
Event Description
Ventral hernia/laparoscopic (b)(6) 2000 at (b)(6) med ctr, (b)(6).Non-healing wound, bowel obstruction, abdominal wall breakdown.Infected prosthetic mesh of abdominal wall ventral hernia repair with mesh (goretex material with 4 titanium screws).My husband has been operated on 3 times in the stomach area.Cut from one end to the other (chest bone down to the pubic hair line).Bowel obstruction/laparoscopic, hernia repair, appendicitis, and removal of infected mesh.Appendicitis (mid-line ex-lap incision 2002-2003).Developed hernia - underwent laparoscopic ventral hernia repair with mesh 2008.Bowel obstruction 2013-2014 period, underwent laparoscopic adhesiolysis.Small bowel obstruction (b)(6) 2014 surgery; partial mesh removal and screws performed from each edge.On(b)(6) 2014 back to or for draining abdominal wound that grew serratia narsens; drained and debrided.Wound was packed.Or again (b)(6) 2014 for abdominal wall breakdown of fascia and more exposed mesh.Not healing.On (b)(6) 2015 infested mesh (remaining) was removed.On (b)(6) 2015 reopen incision for "flush." clean out all infection.
 
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Brand Name
6 GORE SUTURE
Type of Device
SUTURE
Manufacturer (Section D)
GORE
MDR Report Key4799569
MDR Text Key5919856
Report NumberMW5042821
Device Sequence Number2
Product Code GAW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 05/12/2015
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/20/2015
Patient Sequence Number1
Treatment
INSULIN PUMP; VITAMINS; QUINAPRIL; AMITIZA; FISH OIL
Patient Outcome(s) Hospitalization; Disability;
Patient Age66 YR
Patient Weight93
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