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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PERMACOL MESH, SURGICAL

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SOFRADIM PRODUCTION SAS PERMACOL MESH, SURGICAL Back to Search Results
Model Number P152040
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Dyspnea (1816); Edema (1820); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Concomitant products: tet3030 parietex std 3d py 30x30cm x1, (lot # sll00060). (b)(4). 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 an incisional hernia and stomal hernias. It was reported that after the implant, the patient experienced separation of mesh, adhesions, painful bulge, mesh erosion into viscera, obstruction, pneumatosis intestinalis, edema, inflammation, fibrosis, hemorrhages, fibroadipose tissue, foreign body reaction, dyspnea, abdominal pain, and recurrence. Post-operative patient treatment included revision surgery, dissection of mesh, take down of adhesions, small bowel resection with primary anastomosis, primary repair of two enterotomies, wound irrigation, and hernia repair with new mesh.
 
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Brand NamePERMACOL
Type of DeviceMESH, SURGICAL
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
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key10053671
MDR Text Key190889328
Report Number9615742-2020-01072
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/30/2014
Device Model NumberP152040
Device Catalogue NumberP152040
Device Lot Number11B0601
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/13/2020 Patient Sequence Number: 1
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