MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX RND THR 20CM X1

Model Number PCO20FX

Device Problem Material Rupture (1546)

Patient Problems Scarring (2061); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Coma (2417); No Code Available (3191)

Event Date 07/07/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, covidien (b)(4) received an e-mail from a patient, stating that she underwent a laparoscopic surgery by which a mesh was placed in her abdomen to fix a fracture.The patient became more and more ill the days after the surgery and had a very bloated abdomen.On (b)(6) the constation was made that the mesh was ruptured and has been removed that same day by a severe abdomen surgery.During the surgery a piece of bowel was removed that was stuck in the rupture.As a consequence the patient was in coma during 2 days, 1 week of intensive care, 1 week at the nursing dept and now has a horrible vertical scar across her belly.The patient had physical discomfort but also mentally.She followed 2 months of physiotherapy and is being treated by a psychologist.The patient requests info on whether there are any malfunctions in this serial number of the mesh.She also requests whether there are other cases where ruptures have been discovered in the same type of mesh with these consequences.On (b)(6) 2014, (b)(4) manager, was informed by dr (b)(6) requesting information whether a similar incident has occured with our products.(b)(4) replied he was not aware of similar incidents but that he would receive the necessary info to submit a complaint.Surgeon confirmed that he would provide this info.The surgeon also stated that the complaint was not necessarily related to the product, but that the mesh could also have been damaged when inserting it or fixating it with the tacker.Last week the (b)(4) manager requested info from the surgeon, but nothing received to date.This morning (b)(6) 2014 a call took place between (b)(4) and the surgeon.The surgeon stated again that it may not necessarily be a product failure but could also be user error.The surgeon stated he informed someone at covidien before but could not recall who or locate the e-mail.

Manufacturer Narrative

(b)(4).

• Brand Name: PARIETEX PCOX RND THR 20CM X1
• Type of Device: PARIETEX PCOX
• 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 06743 ; 2034925267
• MDR Report Key: 4210290
• MDR Text Key: 5037840
• Report Number: 9615742-2014-00324
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PCO20FX
• Device Catalogue Number: PCO20FX
• Device Lot Number: POA0785X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other