MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. HUBLESS DRAIN; FLAT 7MMX20CM FULL PERFORATED STERILE; WOUND DRAIN

Model Number	360006
Medical Device Problem Codes	Use of Device Problem (1670); Output Problem (3005)
Health Effect - Clinical Codes	Bacterial Infection (1735); Granuloma (1876)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "patient had the following procedure on (b)(6) 2025: neck scar contracture release, flap placement, microliposculpture to trunk, limited facial rejuvenation.The surgeon reported that the right drain was removed about a week later and because of continued induration and a mass, the right lower neck was explored.This showed some unusual wet granulation tissue.Cultures were positive for mycobacterium chelonae along the internal drain track.".
Additional Manufacturer Narrative
The device was not returned for evaluation, and the complaint could not be confirmed.The lot number of the device is not known, however they did provide a list of lot numbers they have in stock so it is assumed it was one of those lots.Each of thos lots were sterilized and released with acceptable results, and all documents were reviewed and found no concerns with any of those lots.There is no evidence to indicate a sterilization failure in any of the referenced lots.Infection is a risk inherent to any invasive medical procedure, and cannot be traced to this device.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: HUBLESS DRAIN; FLAT 7MMX20CM FULL PERFORATED STERILE
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 23607744
• Report Number: 3002750084-2025-00060
• Device Sequence Number: 15932247
• Product Code: GCY
• UDI-Device Identifier: 00840113209989
• UDI-Public: 00840113209989
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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 Model Number: 360006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/10/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 91 KG