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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH NORTH HAVEN - SURGIPRO¿ MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH NORTH HAVEN - SURGIPRO¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPM-35-W
Device Problems Migration or Expulsion of Device (1395); Defective Device (2588); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Arthritis (1723); Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Emotional Changes (1831); Endocarditis (1834); Erythema (1840); Fever (1858); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Scarring (2061); Sepsis (2067); Swelling (2091); Urinary Tract Infection (2120); Chills (2191); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Post Operative Wound Infection (2446); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 hernia. It was reported that after a procedure where this device was implanted, the patient experienced chronic pain, excision, chronic infected mesh, chronic abdominal wound and sepsis. After treatment, the patient experienced removal.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 laparoscopic therapeutic treatment of a bilateral inguinal hernia. It was reported that after the onlay implant, the patient experienced chronic pain, hernia recurrence, mesh migration, infected mesh, abscess, chronic open abdominal wound, soft tissue mass, staphylococcus aureus, phlegmon, positive cocci,inflammation, fibroadipose tissue, foreign body giant cell reaction, scarring, pustule, serosang drainage, mucoid drainage, cellulitis, fibrosis, fibrinous exudate, subcutaneous adipose tissue, redness, swelling, erythema, tenderness, purulent material, hard-nodular area, lump, varicocele, fever, chills, mental status changes, endocarditis, urinary tract infection, septic arthritis, granulation tissue, cutaneous sinuses, unincorporated mesh, sepsis, mental pain, injury, disability, impairment, loss of enjoyment of life and defective mesh. Post-operative treatment included mesh revision surgery, removal surgery, antibiotics, local debridements, admitted to hospital, irrigation and debridement of right knee for septic arthritis, remain on doxycycline long-term as a prophylactic, and wound vac.
 
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Brand NameMESH NORTH HAVEN - SURGIPRO¿
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux CT 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux CT 01600
FR 01600
Manufacturer Contact
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key7675243
MDR Text Key113587947
Report Number9615742-2018-01536
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915526
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,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPM-35-W
Device Catalogue NumberSPM-35-W
Device Lot NumberAIM147
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2022
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: 07/10/2018 Patient Sequence Number: 1
Treatment
UNKNOWN STA-TACK DEVICE
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