MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX COMP 3D PY 12CMCIR NO THRX1; MESH, SURGICAL, POLYMERIC

Model Number PCO12

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Anemia (1706); Erosion (1750); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Emotional Changes (1831); Foreign Body Reaction (1868); Pyrosis/Heartburn (1883); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Nausea (1970); Pain (1994); Scarring (2061); Tissue Damage (2104); Vomiting (2144); Dysphasia (2195); Discharge (2225); Ulcer (2274); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Blood Loss (2597); Abdominal Distention (2601); Weight Changes (2607); Fibrosis (3167); No Code Available (3191)

Event Date 10/01/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.On (b)(6) 2009, the patient underwent a hiatal hernia repair.On (b)(6) 2013 the patient underwent an upper gi endoscopy.In the beginning of (b)(6) 2013, the patient was informed that she suffered damage to her stomach.On (b)(6) 2013 the patient's stomach was removed.The product caused the patient to suffer permanent tissue damage, loss of an essential organ, additional corrective surgeries, significant mental and physical pain and suffering, and economic loss, including, but not limited to, obligations for medical services and expenses.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hiatal hernia.It was reported that after the implant, the patient experienced damage to her stomach, permanent tissue damage, mental and physical pain/suffering, eroded into stomach, acid reflux, barrett's esophagus, dehiscence of mesh, inflammation, serositis, fibrosis, scarring, foreign body reaction, reactive lymph nodes, diverticulitis, narrowing schatzki ring, gi bleed, ulcer, anemia, chest pain, vomiting, obstruction, dysphagia, gerd, painful swallowing, discomfort, abdominal pain, adhesions, low blood pressure, diarrhea, nausea, weight loss, pyrosis, reflux esophagitis, bloating, blood loss, draining mucus, and dysphasia.Post-operative patient treatment included revision surgery, removal of stomach, nissen fundoplication, esophagogastroduodenoscopy with transendoscopic balloon dilation of esophagus, 48-hour bravo esophageal ph capsule, excision of mesh prosthetic at gastroesophageal junction with esophagogastrectomy with total gastrectomy and distal esophagectomy, roux-en-y esophagojejunostomy and jejunojejunostomy, placement of feeding jejunostomy, removal of feeding tube, home health, discharged from home health, transferred to icu, and medications.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hiatal hernia.It was reported that after the implant, the patient experienced damage to her stomach, permanent tissue damage, mental and physical pain/suffering, eroded into stomach, acid reflux, barrett's esophagus, dehiscence of mesh, inflammation, serositis, fibrosis, scarring, foreign body reaction, reactive lymph nodes, diverticulitis, narrowing schatzki ring, gi bleed, ulcer, anemia, chest pain, vomiting, obstruction, dysphagia, gerd, painful swallowing, discomfort, abdominal pain, adhesions, low blood pressure, diarrhea, nausea, weight loss, pyrosis, reflux esophagitis, bloating, blood loss, draining mucus, and dysphasia.Post-operative patient treatment included revision surgery, removal of stomach, nissen fundoplication, esophagogastroduodenoscopy with transendoscopic balloon dilation of esophagus, 48-hour bravo esophageal ph capsule, excision of mesh prosthetic at gastroesophageal junction with esophagogastrectomy with total gastrectomy and distal esophagectomy, roux-en-y esophagojejunostomy and jejunojejunostomy, placement of feeding jejunostomy, transferred to icu, and medications.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hiatal hernia.In (b)(6) 2009, the patient underwent a hiatal hernia repair.In (b)(6) 2013 the patient underwent an upper gi endoscopy.In the beginning of (b)(6) 2013, the patient was informed that she suffered damage to her stomach.In (b)(6) 2013 the patient's stomach was removed.The product caused the patient to suffer permanent tissue damage, loss of an essential organ, additional corrective surgeries, significant mental and physical pain and suffering, and economic loss, including, but not limited to, obligations for medical services and expenses.Additional information from the patient indicates the product used to repair a hiatal hernia had eroded into her stomach and she no longer has a stomach.She experiences acid reflux daily, has to eat small meals, and became lactose intolerant with flare-ups.

• Brand Name: PARIETEX COMP 3D PY 12CMCIR NO THRX1
• 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: lisa hernandez ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6303822
• MDR Text Key: 66598649
• Report Number: 9615742-2017-00017
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: PCO12
• Device Catalogue Number: PCO12
• Device Lot Number: PIC00257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 86