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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM1208GR
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2018
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: one device was returned for investigation. A review of the device history record has been performed and no failure that may relate to the reported conditions have been noted. The visual examination of the returned sample shows that: the sample was returned in its original packaging except the instructions for use (ifu). The sample was returned not contaminated by blood. The textile knitting pattern was found on the incorrect side of the mesh sample. The mesh was found cut all around: -mesh initial dimension: 12 x 8 cm -mesh dimension found: around 9 x 5,5 cm. The flap was well positioned for a tem1208gr (to the right side). The blue marker was found in the left side. The reported condition was confirmed. The blue colored yarn marker, placing on the medial edge of the pre-cut mesh, has no reinforcement role but helps orientation of the mesh. A search of our global complaints database revealed that this was the only report on file for this lot of product. The reported condition was confirmed, manufacturing error. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during an open inguinal hernia procedure, it was found that the packaging label was different from what was inside the box. Replaced by new device to complete the case. There was no patient injury. Upon receipt for investigation, it was noted that the yarn indicator on the mesh. Incorrect positioning of the mesh in the patient could potentially lead to hernia reoccurrence and/or a secondary re-operation to repair.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ PROGRIP¿
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 Key8378724
MDR Text Key137438104
Report Number9615742-2019-00388
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTEM1208GR
Device Catalogue NumberTEM1208GR
Device Lot NumberSSB1167X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2018
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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