MAUDE Adverse Event Report: SOFRADIM PRODUCTION PERMACOL 20X30 1.5MM; MESH, SURGICAL

Model Number 5230-150

Device Problems Material Rupture (1546); Split (2537)

Patient Problems Failure of Implant (1924); Tissue Damage (2104)

Event Date 08/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product or picture were provided for evaluation.A review of the device history record has been performed.This review confirmed that this lot of products was released according to quality assurance specifications.A complaint history review was conducted in which there was no indication of an adverse trend.If additional information is obtained, or the sample is returned, the record will be reassessed.See (b)(4) for investigation of multiple incidents described within this report for this patient.

Event Description

According to the reporter, the patient presented at the hospital for an emergency strangulated hernia repair.The strangulated hernia was repaired with two pieces of 20cmx30cm mesh that were sutured together on the midline.The mesh was under sutured fascia but skin closure could not be achieved.The patient was left with an open abdomen and a vacuum assisted closure (vac) negative pressure dressing over the closed fascia and transferred to the itc.The mesh then split in the lower part of patient's abdomen.The patient was then taken back into the operating room and two more pieces of mesh were inserted into the patient's abdomen.Again, the surgeon couldn't get primary skin closure but the fascia was closed over the mesh.The patient went back to the itu without a vac dressing.The mesh was kept hydrated with wet packs and changed regularly.Again, the mesh tore.The sample was not removed and therefore, will not be returned for investigation.The surgery time was extended beyond 30 minutes but did not result in any further adverse patient consequences.There was unanticipated tissue loss and irreversible damage.There was no blood loss exceeding 500ccs, no extension of the incision, and no conversion to an open procedure.There was no component disengagement.The patient has not yet recovered.Additional information received indicated that the patient does not have cancer.The mesh tore in the bottom corner, not near a suture line nor fixation point.The doctor advised the first tear occurred at 48 hours post-operatively and the second piece within 48 hours.The fistula formation is not located at the rupture of the mesh.The product was not removed and will not be returned for investigation.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).See reference numbers (b)(4) for additional information pertaining to multiple incidents reported for this patient.

Event Description

Additional information has indicated that the patient has passed away on an unknown date.The mesh was ultimately removed and the abdomen was left open.The wet packs were changed daily.The defect that was repaired measured approximately 35cm by 25cm at the widest transverse point.The wound was clean and not infected/contaminated.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Event Description

Additional information has indicated that the patient's cause of death was due to multiple organ failure.It was also reported that the mesh failure did not directly cause death, not being able to achieve deep abdominal closure made it more difficult to achieve a more favorable outcome.Additionally, given the patient's overall conditions and previous health problems contributed the death.

• Brand Name: PERMACOL 20X30 1.5MM
• Type of Device: MESH, SURGICAL
• 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 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5090915
• MDR Text Key: 26289066
• Report Number: 9615742-2015-00082
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 5230-150
• Device Catalogue Number: 5230-150
• Device Lot Number: AOK0635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 150