MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MESH C-QUR V-PATCH; MESH, SURGICAL, POLYMERIC

Model Number 31202

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Customer call received on two different occasions with two different stories regarding a c-qur v patch mesh, injuries mentioned were infection and additional surgery.First call received she stated that she had a mesh implanted in her and wanted the details of batch number and when the item was shipped to the hospital.The second call received she claimed to be an individual from (b)(6) hospital and wanted to know if the 31202 had been recalled.

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Manufacturer Narrative

On 10-may-2022, getinge received an e-mail from the australian senior customer service representative containing customer¿s complaint that involves atrium¿s c-qur v-patch mesh product.The service representative reported that the customer claimed that she was a patient at strathfield private hospital, strathfield, au 2135 where she had an atrium c-qur v-patch implanted.According to the e-mail provided the patient allegedly had an atrium c-qur v-patch mesh implanted and subsequently suffered infection as a result of the implantation of the c-qur v-patch mesh product, which required additional surgery.The date of revision surgery is unknown.The lot number and date of implant is unknown.The patient¿s complaint consists of general allegations.No medical records or other objective evidence is provided for review.There are no liability claim documents provided.No device was returned.Based on these factors, the complaint cannot be confirmed.A complaint history, complaint trend, and capa review did not identify any related complaints, capas, or trends to aid in the investigation; however, it can be noted that a number of complaints associated with mesh litigation were identified.A risk review found that the hazard/harm (reported defect) and associated severity is adequately addressed in the product's risk management file.No details regarding the procedure and the product were provided.Therefore, it is unknown if the product was used in accordance with the labeling.The ifu discloses a number of adverse reactions, including infection, that can occur due to the use of surgical mesh.A definitive root cause of the event cannot be determined; however, the conditions experienced by the patient are anticipated procedural complications.Production of mesh products were discontinued in july 2019.As there have been no adverse trends or new risks associated with this event and no indications of a supplier, design, or manufacturing related cause, no escalation is required for this complaint.H3 other text : device not available for return.

• Brand Name: MESH C-QUR V-PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 14519967
• MDR Text Key: 292789842
• Report Number: 3011175548-2022-00147
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862312027
• UDI-Public: 00650862312027
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K090909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female