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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN IVS TUNNELLER DEVICE MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS UNKNOWN IVS TUNNELLER DEVICE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN IVS TUNNELLER DEVICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Prolapse (2475)
Event Date 08/10/2021
Event Type  Injury  
Event Description
According to literature source of study performed between 2010 and 2020, of the seven hundred forty six patients who underwent surgical procedure for pelvic organ prolapse.  thirty seven patients who underwent mesh augmented repair, the device was used in seventeen patients.  postoperative complications included: prolapse recurrence, three patients experienced hemorrhage, three patients experien ced vaginal mesh exposure. In one case the patient was asymptomatic and treated with topic estrogen.  in the other two cases, the exposure was associated with vaginal discharge and required partial mesh removal in the operation room to treat prolapse recurrence. Three patients did physiotherapy, five were eligible for pessary placement.  twenty eight women underwent native tissue repair surgery, of which twelve were submitted to anterior colporraphy, nine to posterior colporraphy, nine underwent an obliterative procedure - colpocleisis, six sacrospinous ligament fixation and three vaginal hysterectomy.  other complications that were not related to the device included: urinary tract infection to seventeen patients, postoperative fever to eleven patients and vaginal cuff hematoma to three patients. One patient died due to unrelated causes.
 
Manufacturer Narrative
Title: pelvic organ prolapse repair-relapse risk factors: a 10-year retrospective study source: https://doi. Org/10. 1016/j. Gine. 2021. 100712 0210-573x/© 2021 elsevier espana, ¿ s. L. U. All rights reserved. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameUNKNOWN IVS TUNNELLER DEVICE
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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key13009556
MDR Text Key282262831
Report Number9615742-2021-02485
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodePO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN IVS TUNNELLER DEVICE
Device Catalogue NumberUNKNOWN IVS TUNNELLER DEVICE
Was Device Available for Evaluation? No
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/15/2021 Patient Sequence Number: 1
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