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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 TEM2015G
Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Ischemia (1942); Internal Organ Perforation (1987); Injury (2348); Obstruction/Occlusion (2422); Decreased Respiratory Rate (2485); No Code Available (3191)
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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Preoperative and postoperative diagnosis was multiple ventral hernias.The procedure performed was exploratory laparotomy, lysis of adhesions and repair of a ventral hernia with mesh, raising of subcutaneous tissue flaps 7.5cm circumferentially.The patient experienced surgical revision.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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.Product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced recurrence, dense adhesions, ischemic bowel, and perforation of bowel.Post-operative patient treatment included revision surgery, removal of mesh, extensive lysis of adhesions, repair of hernia with mesh, resection of small bowel enterotomy, side-to-side jejunojejunostomy bowel anastomosis, skin flap elevation, excision of skin and subcutaneous tissue, and exploratory laparotomy.
 
Event Description
The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of multiple ventral hernias.It was reported that after implant, the patient experienced recurrence, abdominal pain, dense adhesions, small bowel obstruction, ischemic bowel, perforation of bowel, and respiratory insufficiency.Post-operative patient treatment included revision surgery, removal of mesh, extensive lysis of adhesions, repair of hernia with mesh, resection of small bowel enterotomy, side-to-side jejunojejunostomy bowel anastomosis, skin flap elevation, excision of skin and subcutaneous tissue, and exploratory laparotomy.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.If information is provided in the future, a supplemental report will be issued.
 
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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
MDR Report Key7449710
MDR Text Key106137112
Report Number9615742-2018-00966
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
Report Date 11/26/2019
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 Date05/01/2018
Device Model NumberTEM2015G
Device Catalogue NumberTEM2015G
Device Lot NumberSNE0011
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/23/2018
Initial Date FDA Received04/22/2018
Supplement Dates Manufacturer Received05/15/2019
05/15/2019
Supplement Dates FDA Received08/30/2019
11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age68 YR
Patient Weight82
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