MAUDE Adverse Event Report: Merz North America, Inc (Franksville) Prolaryn Plus; Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

Catalog Number	8044M0K5
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: Prolaryn Plus
• Common Device Name: Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
• Manufacturer (Section D): Merz North America, Inc (Franksville); 4133 courtney street, suite 10; franksville WI 53126
• Manufacturer (Section G): Merz North America, Inc (Raleigh); 6501 six forks rd; raleigh NC 27615
• Manufacturer Contact: juan daccach ; 6501 six forks road; raleigh 27615 ; +1 (919) 582-8000
• MDR Report Key: 50669922
• Report Number: 3013840437-2026-00119
• Device Sequence Number: 15760041
• Product Code: KHJ
• UDI-Device Identifier: 10810235030850
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K013243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8044M0K5
• Device Lot Number: A00262370
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 10/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown