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

Model Number LPG1510AL

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Discomfort (2330); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 a laparoscopic therapeutic treatment of a left inguinal hernia.It was reported that after the implant, the patient experienced severe pain, adhesions, meshoma, twisted and folded mesh, balled up mesh, fibroadipose tissue with fibrosis, mild chronic inflammation, foreign body giant cell reaction to mesh, orchialgia, testicular tenderness, scarring, scrotum filled with air, weakness in indirect space, epigastric vessels were densely encased in mesh, iliac vein very intimately associated with mesh

• Brand Name: PROGRIP
• 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: 11983359
• MDR Text Key: 255667667
• Report Number: 9615742-2021-01441
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513174
• UDI-Public: 10884521513174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120897
• 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
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: LPG1510AL
• Device Catalogue Number: LPG1510AL
• Device Lot Number: PNL0147
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention