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

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.

• Brand Name: SURGIPRO
• Type of Device: MESH, 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 Key: 12026144
• MDR Text Key: 257512293
• Report Number: 9615742-2021-01496
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915526
• Number of Events Reported: 1
• 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 Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/11/2011
• Device Model Number: SPMM-35
• Device Catalogue Number: SPMM-35
• Device Lot Number: A6J792
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/02/2021
• 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