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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 LPG1510X2
Device Problems Degraded (1153); Peeled/Delaminated (1454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2017
Event Type  malfunction  
Manufacturer Narrative
Medtronic complaint number: (b)(4). Evaluation of the device was based on a technical review of all data received from the site, a review of complaint trends and an evaluation of the returned device. The visual examination of the returned sample showed that the mesh was folded and some parts were stuck to the collagen face. The collagen film was incomplete, and the shape of the mesh was modified by a round cut on the white side. Based on the visual examination: the sample was manipulated by the user. The root cause could not be determined. Should new information become available, the file will be opened and the investigation summary amended as appropriate. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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 a laparoscopic bilateral inguinal hernia repair, the doctor was folding the mesh to implant it into the patient. The doctor folded it to one side and then the other and then dipped the mesh in water/saline to get it slightly wet at which time she noticed the "barrier" peeling away from the mesh. It was not inserted into the patient once the damage to the coating was observed. There was no injury as a result of the event. To resolve the issue they opened up another piece of mesh and used that one. The patient status is alive with no injury.
 
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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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6629597
MDR Text Key166709075
Report Number9615742-2017-05157
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberLPG1510X2
Device Catalogue NumberLPG1510X2
Device Lot NumberPRA2443X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/26/2017
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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