MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX LITE; BREAST - ABSORBABLE MESH

Model Number	100027-33
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during a breast reconstruction procedure after mastectomy, a "hair" was found in the galaflex lite packaging.Based on the photo provided and sample evaluation, foreign material (eyebrow hair-like) was observed on top of the inner sterile envelope of galaflex lite.The hair may be presented during the manufacturing process or at the time the sterile pack was opened.Based on the event reported and sample condition the most probable cause of hair presenting is during manufacturing.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, during a breast reconstruction procedure after mastectomy, a "hair" was found in the galaflex lite packaging.Another product was used for the procedure.There was no patient harm or injury.

• Brand Name: GALAFLEX LITE
• Common Device Name: BREAST - ABSORBABLE MESH
• Manufacturer (Section D): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer (Section G): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 25136714
• Report Number: 1213643-2026-00612
• Device Sequence Number: 9543236
• Product Code: OOD
• UDI-Device Identifier: 00810054980797
• UDI-Public: (01)00810054980797(17)271130(10)LXLN0001
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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 Model Number: 100027-33
• Device Catalogue Number: GFLT0022
• Device Lot Number: LXLN0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown