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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 TEM1208GR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Angina (1710); Cellulitis (1768); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pneumonia (2011); Seroma (2069); Thrombosis (2100); Urinary Retention (2119); Hematuria (2558); Blood Loss (2597); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the survey performed there were several complications experienced by the customer when using 8 brands of the company's self gripping mesh, namely inflammation for 25 patients, mesh infection for 15 patients, seroma/hematoma for 12 patients and infection particularly; wound infection, abdominal wall cellulitis and urinary tract infection for 25 patients. There was also pre operative complications, visceral injury, hemorrhage and severe bleeding for 1 patient. The usual post operative complications, were, prolonged ileus, urinary retention, wound complications for 10 patients. Several genital complications were also reported namely; scrotal pain, scrotal swelling, testis discomfort, hydrocele, testis atrophy, orchitis for 15 patients. Other complications were trocar site hernia and incisional hernia for 7 patients, pneumonia, hematuria, deep vein thrombosis, pulmonary embolism and angina pectoris for 2, 15, 3, 2 and 1 patients respectively. However on the listed complications inflammation, genital complications and trocar site hernia and incisional hernia were primarily due to patient condition or procedure related based on the respondent.
 
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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 Key8947645
MDR Text Key156905469
Report Number9615742-2019-02926
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 other
Reporter Occupation
Type of Report Initial
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTEM1208GR
Device Catalogue NumberTEM1208GR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/29/2019 Patient Sequence Number: 1
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