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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 Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/19/2017
Event Type  malfunction  
Manufacturer Narrative
An evaluation was performed on the device. The visual examination of the returned sample shows that the sample was returned in its original packaging: only the inner tyvek pouch was missing. The mesh was found torn from the central pre-cut hole until the opposite edge of the flap. This type of damage would be consistent with high force being applied when opening the flap. It has been cut by the user in particular around the colored yarn marker. The mesh was slightly contaminated by blood. A review of the device history record has been performed. This review confirmed that this lot of products was reviewed and released according to qa specifications the root cause of the observed damage was misuse, excessive manipulation/handling rough by the user is highly suspected. Should new information become available the file will be re-opened and the investigation summary is amended as appropriate. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). Implant and explant date were not provided. Since the lot number was not provided, this information cannot be determined. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter: during an inguinal hernia procedure, before inserting the mesh into the patient, the surgeon was trimming the mesh to the required size and the mesh completely tore in half. The mesh was put to one side and another mesh was opened and used on the patient. The appearance of the mesh was dry.
 
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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
sharon murphy
60 middletown avenue
north haven, CT 06473
2034925267
MDR Report Key6803627
MDR Text Key166709064
Report Number9615742-2017-05205
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model NumberTEM1208GR
Device Catalogue NumberTEM1208GR
Device Lot NumberSQI1087X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2016
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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