MAUDE Adverse Event Report: AMERICAN SURGICAL COMPANY, LLC TELFA

Catalog Number	80-08
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Describe the event or problem: cottonoid count was off with closing count.Went through trash and sterile field multiple times.Surgeon reopened incision for a relook.Took a c arm picture with nothing detected.Called xr tech for flatplate image, again nothing was detected.Placed a cottonoid on patient's skin to see if xr was picking up the cottonoid at all and it was not visible in the image.Package states these cottonoid stings are barrium impregnated so they should be detectable in xray.What was the original intended procedure? not known.What problem did the user have: other.Therapies being used on the patient at the time of the event that may have caused or contributed to the event: not known.

• Brand Name: TELFA
• Common Device Name: TELFA
• Manufacturer (Section D): AMERICAN SURGICAL COMPANY, LLC; 100 cummings center; beverly MA 01915
• Manufacturer (Section G): AMERICAN SURGICAL COMPANY; 100 cummings center; beverly MA 01915
• Manufacturer Contact: amanda lemus ; 100 cummings center; beverly, MA 01915 ; 7815927200
• MDR Report Key: 25452540
• Report Number: 0001221144-2026-00001
• Device Sequence Number: 10450178
• Product Code: HBA
• UDI-Device Identifier: 10749915001708
• UDI-Public: 10749915001708
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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
• Device Catalogue Number: 80-08
• Device Lot Number: 2025/03 BE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White