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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SURGIPRO MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS SURGIPRO MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPMM-35
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Cellulitis (1768); Purulent Discharge (1812); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Scar Tissue (2060); Impaired Healing (2378); 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 bilateral inguinal hernia. It was reported that after the implant, the patient experienced abscess, infected mesh, purulent material, mesh erosion, mesh not attached/free floating, scarring, obliteration of the normal planes, spermatic cord involved, mesh migration, adhesions, open wound, sinus drainage, staphylococcus aureus, bleeding, nonviable subcutaneous tissue, inflammation, scar tissue, and infection. Post-operative patient treatment included incision/drainage of abscess, removal of mesh, purulent material expressed, lavage with saline and betadine, wound debridement, wound was irrigated, fascial defect was loosely reapproximated at the site of the plug with sutures, wound vac, open wound was then copiously irrigated, elliptical incision and subcutaneous dissection, skin/nonviable subcutaneous tissue/some external oblique fascia was excised, bleeding controlled with ligatures of silk, hemostasis was achieved with electrocautery, lysis of adhesions, portions of mesh were left behind due to be too densely adhered and scarred to remove, and sharp excisional debridement of skin/subcutaneous tissue.
 
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Brand NameSURGIPRO
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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12026144
MDR Text Key257512293
Report Number9615742-2021-01496
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
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/11/2011
Device Model NumberSPMM-35
Device Catalogue NumberSPMM-35
Device Lot NumberA6J792
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
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: 06/18/2021 Patient Sequence Number: 1
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