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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 Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 a parastomal hernia. It was reported that after the implant, the patient experienced recurrence, abdominal wall fluid, infection, abscess, adhesions, sinus tract, purulent material, open wound, and leukocytes. Post-operative patient treatment included revision surgery, guided abscess drainage, sinus tract evacuated, wound irrigated/packed, diagnostic laparoscopy, lysis of adhesions, bilateral posterior component separation with bilateral transversus abdominis release, debridement of abdominal wall including skin/subcutaneous tissue/fascia/rectus muscle, removal of mesh, intra-abdominal omental flap, scar revision, wound vac, removal of tacks, purulent material excised, and hernia repair with new mesh.
 
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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
justin ellis
5920 longbow drive
8200 coral sea st ne
mounds view,mn, CT 55112
7635265677
MDR Report Key11610466
MDR Text Key243649994
Report Number9615742-2021-00772
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,Followup,Followup,Followup
Report Date 09/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberTEM1515G
Device Catalogue NumberTEM1515G
Device Lot NumberSQG1364X
Was Device Available for Evaluation? No
Date Manufacturer Received09/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/25/2016
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: 04/02/2021 Patient Sequence Number: 1
Treatment
UNKNOWN SECURESTRAPS
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