MAUDE Adverse Event Report: ASPIDE MEDICAL UNKNOWN

Model Number UNKNOWN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Fever (1858); Pain (1994)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

Due to what is reported by patient, we have no reference of the product, no lot/batch number.Patient received first by laparoscopy a mesh probably for groin hernia, he had pain when he was walking by no pain when laying.A first doctor after examination said exam was fine.A second doctor and examination said that the prosthesis may be not functional as intended, the patient has revision and the surgeon put another mesh overlapping the initial.Comment from the manufacturer: if the surgeon decided to put another mesh that means the surgeon found the initial mesh was not in place in the good area and maybe their was a recurrence or a risk of recurrence, it arrives in laparoscopy surgery when meshes are placed to high in the groin area by the surgeon.This is not a problem of a defective mesh but a problem of surgical procedure not well done or evaluation of the patient file or after revision and the second overlapping prosthesis the patient said he has also fever (he didn't mentioned fever in the previous surgery).He still have pain when working, walking and also during intercourse.Comment from manufacturer : we don't have any knowledge of kind of mesh used, same as the initial, another product, a product from another company.Impossible to say if fever came from surgery, second mesh or anything else.Goring surgery with mesh is an effective and well known surgery since many years, complications are very low but exist, no surgery gives 100% good results, in this case it seems mesh is not fault and as a manufacturer don't have sufficient elements to conduct deeper investigations.

Event Description

Aspide medical received the report number "mw5087705" from the cdrh administration where the following case is described: pt stated that roughly 4 weeks after the initial surgery, he started having pain and lump reappearance, and only had comfort when laying down, while standing up and walking meant excruciating pain.Pt had two f/u appts to address the symptoms.During the first f/u appt, the patient states that he was sitting for 45 mins waiting for the dr and therefore, the lump and pain symptoms were not apparent for the dr.The dr arrived and did a quick palpitation of the area and told the pt he was fine.The pt came back for a second f/u but instead during this time chose to wait for the doctor standing in order to show the dr that his symptoms were true.By the time, the dr appeared, the pt was bunched in pain and the dr did an examination to determine that the mesh wasn't functioning as intended.The doctor recommended physical therapy as result and the pt completed it but it only resulted in more pain.The patient also noted that he is not overweight, takes care of himself, does not smoke, walks everyday, and is healthy for his age.The pt also delineated that the initial surgery was laparoscopic and revision surgery ((b)(6) 2017) was performed via incision.The patient began experiencing body aches and had a fever with a temperature of 104.The doctors were only able to diagnose a fever for the patient and were not able to link it to the mesh.Since then, the patient has had daily pain and feels pain during everyday activities such as work around the house, walking, and pain during intercourse two years later.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): ASPIDE MEDICAL; 246 allée lavoisier; la talaudiere, 42350 ; FR 42350
• Manufacturer (Section G): ASPIDE MEDICAL; 246 allée lavoisier; la talaudiere, 42350 ; FR 42350
• Manufacturer Contact: tadjer sid ahmed ; 246 allée lavoisier; la talaudiere, 42350 ; FR 42350
• MDR Report Key: 9132949
• MDR Text Key: 166191083
• Report Number: 3006617478-2019-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other