MAUDE Adverse Event Report: SIA INC. 10 X 25 CM RECTANGLE MESH; DURASORB MONOFILAMENT MESH

Catalog Number	PTM1025
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported a patient underwent a breast revision procedure involving durasorb (id: ptm1025).An inflammatory response was observed on the inframammary fold (imf), along with micro dehiscence.However, the surgeon was not certain whether the durasorb caused the issue.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The durasorb (id ptm1025) was not returned for evaluation as the product was implanted and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: 10 X 25 CM RECTANGLE MESH
• Common Device Name: DURASORB MONOFILAMENT MESH
• Manufacturer (Section D): SIA INC.; 445 west erie street; 445 west erie street; chicago IL 60654
• Manufacturer (Section G): SIA INC.; 445 west erie street; chicago IL 60654
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22061671
• Report Number: 3015194982-2025-00001
• Device Sequence Number: 15406961
• Product Code: FTL
• UDI-Device Identifier: 00860000875905
• UDI-Public: 00860000875905
• Combination Product (Y/N): N
• PMA/510(K) Number: K181094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 Catalogue Number: PTM1025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown