MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX COMP 30X20CM W THR X1; MESH, SURGICAL, POLYMERIC

Model Number PCO3020F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Contact office phone number: (b)(4) since the lot number was not provided, this information cannot be determined.

Event Description

Literature citation: citation: oommen, cn, nunes, qm, shahzad, k, smart, n, tandon, a (2016).Parietex¿ composite mesh versus dynamesh®-ipom for laparoscopic incisional and ventral hernia repair: a retrospective cohort study.Royal college of surgeons, 6, 568-573.Doi: 10.1308/rcsann.2016.0292 a total of 88 patients underwent laparacopic incisional and ventral hernia repair (livhr) between january 2008 and december 2010.Of these, 82 patients underwent laparoscopic incisional hernia repair, 5 patients had a laparoscopy-assisted procedure and 1 had conversion to open procedure; 39 patients were male and 49 were female.Median follow-up was 53.6 months (range, 40-61 months).Seventy-five patients (85.2%) presented with a primary incisional hernia, ten (11.4%) presented with a first recurrence and three (3.4%) presented with a second recurrence from their previous hernia repairs.Sixty-six patients (75%) had single defect either smaller than 4cm or between 4cm and 10cm; twenty-two patients (25%) had multiple defects.Twenty-six patients underwent livhr with a dynamesh-ipom mesh, and parietex composite mesh was used in 62 patients.The male: female ratio was 1:1.89 in the dynamesh-ipom mesh group and 1:1.07 in the parietex composite mesh group.Bmi was high in 12 patients (46%) in the dynamesh-ipom mesh group and in 35 (56.45%) in the parietex composite mesh group.In 45 patients, only protack was used to fix the mesh, whereas in 43 patients both protack and transfascial suturing were used.Incidence of conversion to open operation was 1.1%.There was no mortality in the study.Overall morbidity was 20.5%.Eight patients (12.9%) in the parietex composite mesh group developed a recurrence and four patients (6.4%) in the parietex composite mesh group (p=0.185) developed a seroma and/or haematoma.Of these, two patients developed a haematoma (this ftr is for haematoma patient #2) in the early postoperative period, which was assessed clinically and with ultrasound, and two patients were diagnosed with a seroma on ultrasound scan 6 weeks postoperatively, which settled spontaneously in follow-up and required no further intervention.

• Brand Name: PARIETEX COMP 30X20CM W THR X1
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473
• MDR Report Key: 6151745
• MDR Text Key: 61785029
• Report Number: 9615742-2016-00194
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCO3020F
• Device Catalogue Number: PCO3020F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR