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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 TEM1515G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Ischemia (1942); Thrombosis (2100); Injury (2348); Impaired Healing (2378); Respiratory Failure (2484)
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 umbilical hernia.It was reported that after implant of the device, the patient experienced issues that included open wound.Treatment for these issues involved application of wound vac, small bowel resection with anastomosis and enterotomy, abdominal wall closure, and placement of new mesh.After these treatments, the patient experienced vent-dependent respiratory failure from undergoing exploratory laparotomy for sma thrombosis and resection of almost the entirety of their small bowel.Provided medical records show that one week after implant of the device, the patient experienced significant issues with abdominal pain, acute mesenteric ischemia, venous congestion and thrombosis.No specific mesh-related issues were noted, and the ischemia / thrombosis treatment that spanned multiple days of icu hospitalization included removal of the mesh.Approximately two weeks after removal, new vicryl mesh was implanted.
 
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Brand Name
PROGRIP
Type of Device
MESH, 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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key8939441
MDR Text Key155801187
Report Number9615742-2019-02891
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521177727
UDI-Public10884521177727
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2019
Device Model NumberTEM1515G
Device Catalogue NumberTEM1515G
Device Lot NumberSOE0129X
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/31/2019
Initial Date FDA Received08/28/2019
Date Device Manufactured05/21/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
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