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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL CORP STRATTICE LAPAROSCOPIC MESH MESH, SURGICAL

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LIFECELL CORP STRATTICE LAPAROSCOPIC MESH MESH, SURGICAL Back to Search Results
Model Number 0608006
Device Problem Output Problem (3005)
Patient Problems Abdominal Pain (1685); Nausea (1970); Hernia (2240); Obstruction/Occlusion (2422)
Event Date 09/29/2016
Event Type  Injury  
Event Description
Upon diagnosis by the emergency physician, it was revealed that i had an extremely large obstructed paraesophageal hiatal hernia which they deemed to be an emergency surgery. I have never had any medical history of any type of hernia, or any hernia diagnosis until the date of (b)(6) 2016. So from around noon timme approx 7 hrs i underwent an emergency surgery to repair the hernia. Shortly after the hernia repair, i started having symptom(s) that i never had a history of having until ater the surgery was performed. I have been hospitalized numerous times since that initial surgery and have had major complications, in which i think it's very important to make you aware of because i have no medical history of any of these severe occurrences until the strattice laparoscopic mesh implant. From (b)(6) 2016 until (b)(6) 2019, i have been hospitalized numerous times with severe complications. I attribute to hernia mesh complications. In which i will provide you with a brief time line of each occurrence for your records. (b)(6) 2016 - initial surgery, dr (b)(6). On (b)(6) 2016, complication after initial surgery - (b)(6), complication of the ability to swallow. On (b)(6) 2016, complication - (b)(6), complication of severe abdominal pain from stomach radiating throughout my abdomen to my back in which a ct scan revealed small bowel obstruction. In (b)(6) 2017, complication - (b)(6), complication of severe abdominal pain radiating throughout my abdomen to my back in which a ct scan revealed small bowel obstruction, which resulted in a painful ng tube being placed down my nose and a lengthy hospitalization. In (b)(6) 2017, complication - (b)(6), complication of severe abdominal pain radiating throughout my abdomen to my back in which a ct scan revealed small bowel obstruction, which resulted in another ng tube being placed down my nose and another lengthy hospitalization for the second time the same month. On (b)(6) 2018, complication - (b)(6), complication of severe abdominal pain radiating throughout my abdomen to my back. On (b)(6) 2018, complication - (b)(6), complication of severe abdominal pain when swallowing inability to vomit, upon ct scan and diagnosis by the emergency physician, it was revealed that the paraesophageal hiatal which had initially been corrected on (b)(6) 2016 had returned and they advised me this was due to a mesh slip or mesh failure. As well as the mesh is capable of causing bowel obstructions especially if portions are breaking off or disintegrating. To consult with add'l surgeon for a revision repair. On (b)(6) 2018 i underwent an upper gi series with (b)(6) in which it revealed i had a recurrent paraesophageal hiatal hernia with approx half of my stomach in my chest cavity. I had a f/u appt with surgeon dr (b)(6) with (b)(6) hosp who advised i did in fact have a surgical need for another repair of the same hernia in which had been previously repaired in less than (24) months time. On (b)(6) 2018, i went to see another surgeon dr (b)(6) with (b)(6) for a second assessment of my situation. That surgeon advised the same recurrent of the initially operated hernia in which he decided that i needed to undergo further testing before a revision surgery. On (b)(6) 2018, i was invited to go to a (b)(6) hockey game with some friends, it was a rare occurrence that i get invited places and was very excited about getting to go. The game started at about 7pm and i made it almost through the first half of the game in which i started experiencing severe abdominal pains, nausea, inability to vomit, and was taken by lifeflight emergency medical services to (b)(6) hosp. In (b)(6) 2018, i had a f/u with surgeon dr (b)(6) at the (b)(6) who advised the need for a revision surgery of the hernia in which was repaired on (b)(6) 2016 in which the strattice laparoscopic mesh was implanted, he advised the need to remove any remaining portions of the product and advised against using any further mesh product for the correction of this hernia and a complete revision of the initial repair as he felt this product was not an appropriate corrective measure and one that (b)(6) med ctr did not use. On (b)(6) 2019, revision surgery - (b)(6). On (b)(6) 2019, post surgical check up - dr (b)(6), (b)(6) medical center in which my health has improved since the revision surgery. I am enclosing for your record a copy of the hosp implant record in which shows all of the relative info regarding your company and product.
 
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Brand NameSTRATTICE LAPAROSCOPIC MESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL CORP
MDR Report Key8439738
MDR Text Key139556655
Report NumberMW5085057
Device Sequence Number0
Product Code FTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number0608006
Device Lot NumberSP100317 - 005
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/20/2019 Patient Sequence Number: 1
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