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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP MESH; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PROGRIP MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PROGRIP
Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Unspecified Infection (1930); Perforation (2001); Sepsis (2067); Septic Shock (2068); Seroma (2069); Discharge (2225); Injury (2348)
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 an abdominal wall hernia.It was reported that after implant, the patient experienced abscess, omental and small bowel adhesions, seroma, and perforated viscus.Post-operative patient treatment included revision to progrip and lysis of adhesions.
 
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.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.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an abdominal wall hernia.It was reported that after implant, the patient experienced abscess, omental and small bowel adhesions, seroma, intra-abdominal sepsis, septic shock, drainage, mesh incorporated in tissues, pus was filling left lower quadrant of abdomen and pelvis, discoloration of the serosal surface of the rectal area that was walling the infection/asceses, and perforated viscus.Post-operative patient treatment included revision to progrip, incision and drainage of intra-abdominal abscess, and lysis of adhesions.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an abdominal wall hernia.It was reported that after implant, the patient experienced abscess, omental and small bowel adhesions, seroma, intra-abdominal sepsis, septic shock, drainage, mesh incorporated in tissues, pus was filling left lower quadrant of abdomen and pelvis, discoloration of the serosal surface of the rectal area that was walling the infection/ascess, and perforated viscus.Post-operative patient treatment included revision to progrip, incision and drainage of intra-abdominal abscess, and lysis of adhesions.
 
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.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 Name
PROGRIP MESH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key8442231
MDR Text Key139533854
Report Number9615742-2019-00590
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 10/11/2019
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 Model NumberUNKNOWN PROGRIP
Device Catalogue NumberUNKNOWN PROGRIP
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/27/2019
Initial Date FDA Received03/21/2019
Supplement Dates Manufacturer Received05/15/2019
05/15/2019
Supplement Dates FDA Received08/28/2019
10/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient Weight90
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