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

Model Number LPG1510AR

Device Problems Degraded (1153); Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Distress (2329); Discomfort (2330); Injury (2348); Disability (2371); Ambulation Difficulties (2544); Blood Loss (2597); Abdominal Distention (2601); Weight Changes (2607); No Code Available (3191); Paresthesia (4421); Cramp(s) /Muscle Spasm(s) (4521); 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 implant, the patient experienced an unspecified adverse outcome.Treatment provided for these conditions include potential revision.

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 implant, the patient experienced an abdominal pain, pain in other areas, rectal hemorrhage and superior mesenteric artery syndrome.Treatment provided for these conditions include potential revision.

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 an inguinal hernia.It was reported that after implant, the patient experienced defective device, mental pain, disability, impairment, loss of enjoyment of life, mesh tearing, mesh degradation, mesh contracting, inflammation, mesh adhering, mesh erosion, scar tissue, nerve damage, pulling/tugging sensation, burning sensation, spasms, tingling sensation, swollen ankles, nausea, leaking sensation, mesh frayed and migrated, abdominal pain, pain, rectal hemorrhage, lump in abdomen, bleeding in stool, significant weight loss, inability to lift items greater than 30 lbs, limp in his gait, bloating, infection, tenderness, emotional distress, disintegration of mesh, and superior mesenteric artery syndrome.Post-operative patient treatment included medical treatment, medication for pain, and admission to hospital.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an inguinal hernia.It was reported that after implant, the patient experienced an abdominal pain, pain, rectal hemorrhage, lump in abdomen, bleeding in stool, significant weight loss, inability to lift items greater than 30 lbs, limp in his gait, bloating, infection, tenderness, emotional distress, disintegration of mesh, and superior mesenteric artery syndrome.Post-operative patient treatment included medical treatment, medication for pain and admission to hospital.

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.

• 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, CT 80301 ; 3035816943
• MDR Report Key: 7951717
• MDR Text Key: 123234788
• Report Number: 9615742-2018-02257
• Device Sequence Number: 1
• Product Code: FTL
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: LPG1510AR
• Device Catalogue Number: LPG1510AR
• Device Lot Number: PPB0758X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2022
• Date Device Manufactured: 02/25/2015
• 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): Hospitalization; Required Intervention; Other; Disability
• Patient Age: 34 YR
• Patient Sex: Male