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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS SYMBOTEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SYM2520
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Erythema (1840); Unspecified Infection (1930); Perforation (2001); Sepsis (2067); Swelling (2091); Hernia (2240); Injury (2348); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: ethicon securestrap w/12 straps (product id: strap12, lot number: jh6734) ethicon securestrap w/25 straps (product id: strap25, lot number: jjl6442) sym9 stex rnd 9cm x1 (product id: sym9, lot number: pqc0895x) sym15 stex rnd 15cm x1 (product id: sym15, lot number: ppe0062x). (b)(4). 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 ventral incisional hernia. It was reported that after the implant, the patient experienced infection, abdominal pain, swelling, diarrhea, erythema, sepsis, adhesions, mesh erosion, perforation, abscess, enteric contamination, leukocytosis, and recurrence. Post-operative patient treatment included revision surgery, small bowel resection, negative pressure dressing, removal of mesh, transferred to icu, resuscitation, rectus myofascial advancement flaps, hernia repair with new mesh, excision of redundant skin and subcutaneous tissue with electrocautery, and enterotomy repaired.
 
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Brand NameSYMBOTEX
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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key10173751
MDR Text Key195731142
Report Number9615742-2020-01313
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberSYM2520
Device Catalogue NumberSYM2520
Device Lot NumberPQA0469X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/23/2016
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: 06/19/2020 Patient Sequence Number: 1
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