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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 LPG1510AL
Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); Numbness (2415); Abdominal Distention (2601); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product: lpg1612ar lpg1612ar 12x16cm lap progrip rt, lot number: rpi0584x. 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 the implant, the patient experienced chronic pain, hernia recurrence, symmetric left-sided parasymphyseal reactive edema, bulging mass, inguinodynia, numbness, tenderness, achiness, mesh clamshelled, adhesions, testicles swollen, bloated, and nerve damage. Post-operative patient treatment included revision surgery, medication, partial removal of mesh, and nerve blocks.
 
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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 80301
3035816943
MDR Report Key12217690
MDR Text Key263142951
Report Number9615742-2021-01798
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521513174
UDI-Public10884521513174
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Model NumberLPG1510AL
Device Catalogue NumberLPG1510AL
Device Lot NumberRPI0117X
Was Device Available for Evaluation? No
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/09/2015
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: 07/23/2021 Patient Sequence Number: 1
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