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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); Adhesion(s) (1695); Fever (1858); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypoxia (1918); Inflammation (1932); Pneumonia (2011); Seroma (2069); Tachycardia (2095); Urinary Tract Infection (2120); Hernia (2240); Abdominal Distention (2601); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Concomitant product: pco8vp pco ventral patch 8 cm x1 (lot# prk1454x), reltack4xdpt reliatack device 4 deeppurc (lot# n7g0369urx). (b)(4). 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 hernia. It was reported that after implant, the patient experienced adhesions, recurrence, inflammatory lesions, hemorrhages, foreign body giant cell reaction, inflammation, abdominal pain, uti, bloating, loss of domain, pneumonia, fever, tachycardia, hypoxia, and seroma. Post-operative patient treatment included additional surgery, revision, bowel removal, lysis of adhesions, primary anastamosis, enterotomy repair, reconstruction of abdominal wall with bilateral component separation, hernia repair with new mesh, fascial closure, negative pressure wound management system, medication, wound vac, drain, and mesh removal.

 
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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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key11135197
MDR Text Key225731129
Report Number9615742-2021-00103
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 02/01/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2019
Device MODEL NumberTEM1515G
Device Catalogue NumberTEM1515G
Device LOT NumberSOK0345X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/26/2014
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: 01/07/2021 Patient Sequence Number: 1
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