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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 LPG1510AK2
Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Inflammation (1932); Nerve Damage (1979); Pain (1994); Pulmonary Dysfunction (2019); Scar Tissue (2060); Scarring (2061); Swelling (2091); Hernia (2240); Injury (2348); Ambulation Difficulties (2544); Abdominal Distention (2601); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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 resulting in an unspecified adverse outcome. The product was used for therapeutic treatment. The preoperative diagnosis was right inguinal hernia. The procedure performed was a repair of the hernia with mesh, plug and patch technique. It was reported that after the procedure, the patient experienced excruciating abdominal pain, abdominal swelling, difficulty walking, pain and suffering, economical losses, scarring, hernia recurrence, and mesh revision surgery.
 
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 an inguinal hernia. The procedure performed was a repair of the hernia with mesh, plug and patch technique. It was reported that after the procedure, the patient experienced excruciating abdominal pain, abdominal swelling, difficulty walking, pain and suffering, economical losses,scarring, hernia recurrence. Post-operative patient treatment included revision surgery.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 an inguinal hernia in a laparoscopic repair. The procedure performed was a repair of the hernia with mesh, plug and patch technique. It was reported that after the procedure, the patient experienced excruciating abdominal pain, abdominal swelling, difficulty walking, pain and suffering, economical losses, scarring, hernia recurrence. Post-operative patient treatment included revision surgery and repair of hernia with mesh.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.  the fda was notified of this large complaint receipt.   due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 an inguinal hernia. The procedure performed was a repair of the hernia with mesh, plug and patch technique. It was reported that after the procedure, the patient experienced excruciating abdominal pain, abdominal swelling, difficulty walking, pain and suffering, economical losses,scarring, hernia recurrence. Post-operative patient treatment included revision surgery and repair of hernia with mesh.
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The preoperative diagnosis was right inguinal hernia. The procedure performed was a repair of the hernia with mesh, plug and patch technique. The product has caused the patient severe and permanent bodily injuries, including but not limited to excruciating abdominal pain and swelling, difficulty walking, and physical pain and suffering, and economical loss. Additionally, the patient will have to undergo subsequent surgeries to remove and/or repair the damage and injuries caused by the products.
 
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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 Key6724608
MDR Text Key119406941
Report Number9615742-2017-05188
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Model NumberLPG1510AK2
Device Catalogue NumberLPG1510AK2
Device Lot NumberZPK0510
Was Device Available for Evaluation? No
Date Manufacturer Received02/09/2022
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: 07/19/2017 Patient Sequence Number: 1
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