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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX PROGRIP MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM1509G
Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Hernia (2240); Complaint, Ill-Defined (2331); Injury (2348); Impaired Healing (2378); Abdominal Distention (2601)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of incisional hernia. It was reported that after a procedure where this device was implanted, the patient experienced an unspecified adverse outcome.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced infected mesh with fistulization to the skin, recurrence, adhesions, open wound with staphylococcus aureus, bulging, pain, mesh migration, and light purulent non-odorous draining sinus in the midline laparotomy wound. Post-operative patient treatment included surgical revision, hernia repair with new mesh, mesh debridement, and mesh removal. Relevant tests/laboratory data: (b)(6) 2014: op note stated ct scan revealed the recurrence is just to the left side of the previously placed herniorrhaphy mesh in the low epigastrium. Large hernia sac bulging to the left of midline. (b)(6) 2015: op noted stated 2 ed visits with ct scans concerning for small bowel fistulization. Cultures of wound revealed staphylococcus aureus.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMESH SOFRADIM - PARIETEX PROGRIP
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
MDR Report Key7710634
MDR Text Key114717797
Report Number9615742-2018-01686
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2015
Device Model NumberTEM1509G
Device Catalogue NumberTEM1509G
Device Lot NumberSLA00407
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/23/2018 Patient Sequence Number: 1
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