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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 P152030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Adult Respiratory Distress Syndrome (1696); Fever (1858); Fistula (1862); Necrosis (1971); Sepsis (2067); Seroma (2069); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Concomitant devices: adhesion barrier seprafil membrane bioresorb- product id: 4301-02, lot #: 06np255u, exp. Date: 08-01-2009. 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 ventral hernia. It was reported that after the implant, the patient experienced large amount of bowel within the subcutaneous tissue dehisced around the edges, multiple dilated proximal small loops of bowel, adhesions, abscess, necrotic fascia, abdominal compartment syndrome and ileus, fistula, succus drainage, fistula occlusion, seroma, fever, abdominal pain, fascial dehiscence, serous fluid from wound, edematous bowel, small bowel obstruction, acute gangrenous cholecystitis, central line sepsis, and open abdominal granulation wound. Post-operative patient treatment included mesh removal surgery of previously placed permacol patch, abdominal vac placed, enteric contents were milked back into the stomach and aspirated through the ng tube, wound vac, lysis of adhesions, debriding of necrotic fascia, sump drain for small bowel fistula, split thickness skin grafts harvested from the left leg using a dermatome and applied to entire abdominal wall, removal of wound vac, tube enterostomy, hernia repair with mesh, abdominal washout, hospitalization, icu, peritoneal lavage, drainage of enterocutaneous fistula, cholecystotomy tube, closure of small bowel fistula, small bowel resection, small bowel side-to-side bppvass [sic] of the site of small bowel obstruction, gastrostomy tube, repair of massive incision with alloderm, and skin/subcutaneous flaps with skin/subcutaneous tissue relaxing, and revision surgery.
 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12025430
MDR Text Key258874404
Report Number9615742-2021-01473
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,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/25/2009
Device Model NumberP152030
Device Catalogue NumberP152030
Device Lot Number06B08-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
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: 06/18/2021 Patient Sequence Number: 1
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