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

Model Number SPM-35-W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Hernia (2240); Impaired Healing (2378); Hematuria (2558); Abdominal Distention (2601); Unspecified Tissue Injury (4559)

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 right inguinal hernia. It was reported that after the implant, the patient experienced hernia recurrence, bleeding vessel/oozing throughout wound, hematuria, open wound, bulge, hematoma, and active bleeding in internal oblique muscle. Post-operative patient treatment included revision surgery, evacuation of right groin hematuria, wound exploration, wound vac, hernia repair with new mesh, mesh dissected off external oblique aponeurosis, secure ligation of bleeding vessel and internal oblique muscle, and mesh removal.

• 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: 12324643
• MDR Text Key: 266659130
• Report Number: 9615742-2021-01980
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521101371
• UDI-Public: 10884521101371
• 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: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/20/2014
• Device Model Number: SPM-35-W
• Device Catalogue Number: SPM-35-W
• Device Lot Number: A9M0714
• 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: 08/19/2021
• 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: 08/16/2021 Patient Sequence Number: 1