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

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.

• Brand Name: PERMACOL
• Type of Device: MESH, 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 Key: 12025430
• MDR Text Key: 258874404
• Report Number: 9615742-2021-01473
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• 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 Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/25/2009
• Device Model Number: P152030
• Device Catalogue Number: P152030
• Device Lot Number: 06B08-1
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/25/2021
• 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