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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NamePROGRIP
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, CT 80301
3035816943
MDR Report Key7951717
MDR Text Key123234788
Report Number9615742-2018-02257
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120897
Number of Events Reported1
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 Received10/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2016
Device Model NumberLPG1510AR
Device Catalogue NumberLPG1510AR
Device Lot NumberPPB0758X
Was Device Available for Evaluation? No
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/25/2015
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: 10/10/2018 Patient Sequence Number: 1
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