MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MESH PROLITE ULTRA SHEETS; MESH, SURGICAL, POLYMERIC

Model Number	30714
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Erectile Dysfunction (4511)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: sections d4 - lot # and expiration date and h4.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: section d9, e1 - email address & h6 investigation summary: a review of the case details does not suggest that the only factor was the hernia mesh that was implanted.Other likely factors include but are not limited to, the patient¿s obesity, preoperative pain, diabetes, direct hernia defect with cord lipoma, surgical technique and patient¿s foreign body reaction.Based on the details provided and review of the device history records and surgical notes the complaint cannot be confirmed to be the fault of the atrium prolite ultra mesh.It should be noted that uncoated mesh product family production was discontinued in july 2019.See production memo attached.As the prolite ultra mesh is no longer manufactured obtaining a contemporaneous sample from inventory is not possible.A complaint history, complaint trend, and capa review did not identify any related complaints, capas, or trends to specifically aid in the investigation.A number of complaints involving 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.Based on the details provided, it does appear the device was used in accordance with the labeled indications for use.The ifu discloses a number of adverse reactions, including pain and the need for surgical revision, 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.Although there is no specific allegation of device failure, the patient reported clinical issues following a 2019 implant and the complaint should be considered confirmed.Production of mesh products were discontinued in july 2019.As there have been no new risks associated with this event.There is 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: section a2, a4, a5, a6 - black african american, d6a & h6.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: section b5, b6, b7, h10.B7 continued: osteoarthritis, essential tremor, tubular adenoma of colon, supraventricular tachycardia, iron deficiency anemia, dysphagia, obstructive sleep apnea syndrome, sensorineural hearing loss, reflux disease, esophagitis, urethral stricture, pulsatile tinnitus, restrictive lung disease, primary aldosteronism, constipation, enlarged prostate, primary cutaneous b-cell lymphoma, and low back pain.
Event or Problem Description
Additional information received patient also experienced sexual disfunction and urinary tract infection.
Event or Problem Description
We received a call/voicemail from a customer.The message he left was general and stated he had questions about his implant.When i spoke with the man yesterday he claimed that he experienced clinical issues with his implant.Implanted 2019.Patient experienced pain, migrated mesh, nerve ingrowth.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: MESH PROLITE ULTRA SHEETS
• Common Device Name: 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: 19388862
• Report Number: 3011175548-2024-00119
• Device Sequence Number: 6776271
• Product Code: FTL
• UDI-Device Identifier: 00650862307146
• UDI-Public: 00650862307146
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K002093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: 30714
• Device Catalogue Number: 30714
• Device Lot Number: 439223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 05/24/2024; 05/24/2024; 07/09/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/04/2024; 06/06/2024; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic