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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION PARIETEX COMP 3D PY 12CMCIR NO THRX1 MESH, SURGICAL, POLYMERIC Back to Search Results
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
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.
 
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).
 
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Brand NamePARIETEX COMP 3D PY 12CMCIR NO THRX1
Type of DeviceMESH, 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 Key6303822
MDR Text Key109777147
Report Number9615742-2017-00017
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
Number of Events Reported1
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 Received02/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2013
Device Model NumberPCO12
Device Catalogue NumberPCO12
Device Lot NumberPIC00257
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
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 Treatment Data
Date Received: 02/06/2017 Patient Sequence Number: 1
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