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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 SYM15F
Device Problems Degraded (1153); Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2017
Event Type  malfunction  
Manufacturer Narrative
The visual examination of the returned sample shows that the sample was returned in its original aluminum pouch. The sample was found contaminated by blood. The mesh diameter is around 10 cm and the blue marker is not placed in the middle of the mesh. The mesh was found torn from the left of the blue marker, until the bottom of the mesh. A blue yarn suture is found from the tear. A hole about 3 cm diameter was found in the left side of the marker. In one quarter of the mesh (under the blue marker until the tear), the collagen was found flaking on the edge and lacking in nearly all of this part. The investigation has concluded that excessive tension is highly suspected. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a laparoscopic parastomal hernia repair procedure, while the mesh was being attached to the hernia defect, the device¿s mesh was damaged, wherein collagen film peeled off in the middle of the mesh in one area and the collagen was flaking around the outside. Saline was used to hydrate the mesh. Another piece of mesh was opened and used in order to resolve the issue. A 10/12 trocar was used. No patient injury.
 
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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 Key7112345
MDR Text Key175489353
Report Number9615742-2017-06030
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYM15F
Device Catalogue NumberSYM15F
Device Lot NumberPRG0426X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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