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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 P151520
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Pannus (1447); Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Cramp(s) (2193); Hernia (2240); Discomfort (2330); Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(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. It was reported that after the onlay implant, the patient experienced adhesions, recurrence, abdominal pain, exacerbation, crampy associated with meals, contracted scar tissue, painful left side pannus with panniculitis, inflammation, necrosis, discomfort, pain, and infection. Post-operative patient treatment included revision surgery with additional implant, reconstruction of midline ventral hernia with left sided muscle flap, direct repair of left incisional hernia, abdominal panniculectomy, explantation of retained abdominal mesh with sutures, complex repair, removal of contracted scar tissue, removal of mesh, dermal/fat graft to abdominal wall, complex repair of abdominal wall skin defect, removal of hernia sac, hernia repaired in a vest over pants style, and lysis of adhesions.
 
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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 Key9883808
MDR Text Key185912197
Report Number9615742-2020-00649
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
Type of Report Initial
Report Date 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/17/2009
Device Model NumberP151520
Device Catalogue NumberP151520
Device Lot Number06B10-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
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: 03/26/2020 Patient Sequence Number: 1
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