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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 TEM1208GR
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Hernia (2240); Impaired Healing (2378); Fibrosis (3167); Unspecified Tissue Injury (4559)
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 the implant, the patient experienced mesh failure, recurrence, infection, chronic abdominal wound, fibrosis, mental pain, pain, disability, impairment, loss of enjoyment of life, bowel necrosis, fistula, adhesions, bowel deserosalization, bowel erosion, enterotomy, defective mesh, and inflammation. Post-operative patient treatment included bowl resection, and excision of chronic abdominal wound.
 
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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 Key13190874
MDR Text Key283395946
Report Number9615742-2022-00011
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081050
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
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberTEM1208GR
Device Catalogue NumberTEM1208GR
Device Lot NumberSPF0620X
Was Device Available for Evaluation? No
Date Manufacturer Received12/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/08/2015
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: 01/07/2022 Patient Sequence Number: 1
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