MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX 3DR; ABSORBABLE MESH

Model Number	100043-04
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the galaflex 3dr sterile packaging was ripped/compromised whereas the product box was intact.Evaluation of the returned sample find there was no tears, rips, or holes in the inner sterile tyvek pouch.The pouch was opened at point of use with no anomalies.There are no issues with seal transfer indicating the pouch was properly sealed.Based on the sample condition there a breach of the sterile barrier is not confirmed.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june 2023.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 an augmentation mastopexy procedure, it was found that sterile packaging of galaflex 3dr was ripped/compromised whereas the product box was intact.It was reported that the mesh was not used and another galaflex mesh was used to complete the procedure.There was no patient injury.

• Brand Name: GALAFLEX 3DR
• Common Device Name: 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: 20152969
• Report Number: 1213643-2024-00445
• Device Sequence Number: 4248645
• Product Code: OOD
• UDI-Device Identifier: 00810054980032
• UDI-Public: (01)00810054980032(17)261219(10)LXHS0030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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: 100043-04
• Device Catalogue Number: FR3D04
• Device Lot Number: LXHS0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2023
• 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: Female