MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNKNOWN PARIETEX PRODUCT

Model Number UNKNOWN PARIETEX

Device Problem Entrapment of Device (1212)

Patient Problems Abscess (1690); Bacterial Infection (1735); Edema (1820); Fatigue (1849); Fever (1858); Inflammation (1932); Staphylococcus Aureus (2058); Chills (2191); Hernia (2240); Therapeutic Response, Decreased (2271); Reaction (2414); Abdominal Distention (2601); Fluid Discharge (2686)

Event Type  Injury  

Event Description

Case report a (b)(6)-year-old white male with hypertension, hyperlipidemia, former smoker who quit over 30 years before presentation, had bilateral open inguinal hernia repairs in his 20s.He developed a recurrent left inguinal hernia in 1999, which was treated with a laparoscopic transabdominal repair.In 2010, he experienced a symptomatic recurrence on the contralateral side.He was seen in clinic at our institution, and he agreed to a recurrent right inguinal hernia repair by a tep approach.The operation was uncomplicated and straightforward.A 6 to 4-inch parietex anatomic mesh (covidien, b)(4)), was used and a thin layer of a fibrin sealant (2 ml tissel; baxter, (b)(4)) was sprayed using a cannula to secure the mesh in the preperitoneal place.The patient was discharged home the same day and returned to his activities 1 week after the operation.The patient did very well for 3 years without any complication.In 2013, he presented after he noticed a "pop" and an enlarging right inguinal bulge.In addition, he also experienced increasing fatigue, fevers and chills, and he lost approximately 30 lbs over the past 2 months.An abdominal computed tomography was obtained, revealing a multiloculated retroperitoneal fluid collection measuring 5.4 to 10.4 cm (figs.1, 2).He was admitted to the hospital, placed on iv piperacillin and tazobactam followed by percutaneous drainage of the retroperitoneal abscess.His antibiotic coverage was changed to ampicillin/sulbactam, as the cultured abscess fluid returned (b)(6).The goal of percutaneous drainage was to adequately drain the abscess cavity and reduce the inflammatory reaction in the groin in preparation for mesh removal and repair of the hernia defect.He underwent a colonoscopy to ascertain potential causes for the mesh infection.No lesions suspicious for malignancy were found on colonoscopic evaluation, although a mild cecal colitis was noted.The patient subsequently underwent elective excision of his right inguinal mesh, and repair of the hernia defect with biological mesh.During the operation, significant inflammation and edema was encountered during the dissection in the right inguinal area.The mesh was found correctly placed under the right rectus, with its inferomedial aspect embedded in the pubic bone.Once the mesh was completely removed without damaging the cord structures, a resulting 4 to 6 cm defect in the floor of the inguinal canal was closed with a biological mesh, allomax surgical graft (davol (b)(4)) and secured with 2-0 prolene to the inguinal ligament, conjoint tendon, and internal oblique muscle.The wound was left open and a v.A.C.(kci, (b)(4)) dressing was applied, with the goal of reducing the risk of seroma and infection.At 2-week follow-up, the patient's incision was healing well.At 8-month follow-up, the patient was doing well without any hernia recurrence or wound complications.

Manufacturer Narrative

(b)(4).

• Brand Name: UNKNOWN PARIETEX PRODUCT
• Type of Device: UNKNOWN PARIETEX PRODUCT
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletwon ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4714542
• MDR Text Key: 5667415
• Report Number: 9615742-2015-00027
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 78 YR