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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROSUP

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SOFRADIM PRODUCTION SAS PROSUP Back to Search Results
Model Number PACLGK01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Purulent Discharge (1812); Fatigue (1849); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Depression (2361); Post Operative Wound Infection (2446); Prolapse (2475); Decreased Sensitivity (2683); Taste Disorder (4422); Sexual Dysfunction (4510); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the patient had multiple procedures; the 1st intervention was on (b)(6) 1995, cystocele treated by anterior colposuspension under laparoscopic surgery. Introduction of the verres needle in the periumbilical area, safety manoeuvre, creation of the pneumoperitoneum, introduction of the first trocar in open coelio n°10 for the laparoscope, normal abdominal inspection, a few adhesion flanges in the left adnexa. Incision of the anterior parietal peritoneum between the two umbilical arteries giving access to the retzius. Liberation of the anterior surface of the bladder, of two cooper, on the right and on the left. Dissection of the lateral cul-de-sacs on the right and left. Placement of a different maker no. 0 reverse ski needle thread threading the cooper's tendon and the right cul de sac, identical maneuver for the left side, ligation with a different fabricator instrument. The cul-de-sacs are brought to approximately 1 cm from the inferior edge of the cooper's tendon on each side. The control of the cystocele reduction seems satisfactory. Closure of the anterior parietal peritoneum by an overjet of p. D. S n°0 knotted extracorporeally. Abdominal inspection. At the end of the operation, verification of the trocars, exsufflation, closure of the orifice of the 10 mm trocar by a stitch of a suture of a different company n°0. Separate stitches on the skin. There were numerous vaginal and urinary infections noted. There was a 2nd surgery on (b)(6) 2012, transobturator tape procedure plus promontofixation plexy placement of the optic in left para umbilical. Realization of the pneumoperitoneum under visual control. Exploration reveals a slightly enlarged uterus with a posterior fibroid. Placement of the various operating trocars. Opening of the pre-vesical peritoneum. Vesico uterine and then vesico vaginal detachment. During the vesico-vaginal dissection, the caesarean scar was a problem. A small punctiform perforation of the bladder is made, sutured with a thread from a different organization. Opening of the douglas peritoneum. Recto vaginal detachment pushed far up to the level of the levators which are repeated on each side. Placement of a posterior strip fixed to the levators, a vaginal stitch and two stitches on the utero sacral, an anterior strip fixed by 3 stitches at the vaginal level. Fenestration of the broad ligament. Passage of the anterior strip on the right side of the uterine cervix. Approach of the promontory. Location of the anterior common vertebral ligament. Pexy of the strips to the promontory via suture of a different company n°1 point. Peritonization with 3 company branded suture bursae. Verification of the hemostasis. Aspiration of the pneumoperitoneum after checking the entry points. Absorbable closure on the skin. It was concluded two inter recto inter vesico vaginal prostheses. Sub-urethral infiltration. Longitudinal incision of 1 cm. Lateral bladder detachment with the scissors allowing to find the obturator region on each side. Passage of a needle through the obturator membrane and externalized through the inguinal fold. Passage of two wires at this level. Positioning of a sub urethral strip without tension. Vaginal closure with a suture from a different producer. Cutaneous closure with absorbable thread. In (b)(6) 2013, there was a bladder wound during the intervention, pain in the lower abdomen, urinary infection with important germs, recurrence of prolapse, pain in the back and pelvis and the patient was very tired. The last procedure was a new promontofixation on (b)(6) 2014, plate for cure of prolapse by high approach. The patient was always painful with recurrent urinary and vaginal infections, in repetitions with a lot of pus and vaginal discharge, fatigue, depression, no taste for anything and sensitive intimate relations.
 
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Brand NamePROSUP
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 Key12051487
MDR Text Key258113354
Report Number9615742-2021-01549
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Model NumberPACLGK01
Device Catalogue NumberPACLGK01
Device Lot NumberPMB00588
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/08/2012
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: 06/23/2021 Patient Sequence Number: 1
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