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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TMP2008G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Shock (2072)
Event Date 03/17/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, based on clinical study, a patient who undergone posterior pelvectomy for synchronous rectal and uterine cancer, had suffered from wall hematoma and hemorrhagic shock on retromuscular bleeding at the prosthesis level was assessed and might be related to the mesh rather than the procedure. Reason for mesh removal; hypovolemic shock due to active bleeding of inferior epigastric vessels, the mesh was removed because a reintervention was required and thus, a risk of mesh infection would be increased. Cbc, ct-scan, and bacterial culture were done to the patient. The mesh was removed on (b)(6) 2021. This caused extended hospital stay for 10 days. The patient was also treated with blood transfusion of 7 units and plasma 3x. Patient's surgical history include de-functioning colostomy/laparotomy. Patient's co-morbidities include hypercholesterolemia, epilepsy and atrial fibrillation (requiring anticoagulation).
 
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Brand NamePROGRIP
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key11688530
MDR Text Key246225780
Report Number9615742-2021-00863
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K142900
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTMP2008G
Device Catalogue NumberTMP2008G
Device Lot NumberSUH0249X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/19/2021 Patient Sequence Number: 1
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