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

Model Number	100042-01
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, received galaflex 3dr box was damaged, sterility compromised.The subject device was not returned for evaluation.Based on the information available and without having the sample to evaluate, no conclusions can be made.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.Note, the date of event is considered to be a best estimate as 27-jan-2025 based on the date of awareness.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, when received the galaflex 3dr mesh box was found to be damaged and the internal wrapper of the mesh packaging was also breached which compromised the sterility.The mesh was not used and there was no patient involvement.
Additional Manufacturer Narrative
As reported, received galaflex 3dr box was damaged, sterility compromised.The subject device was not returned for evaluation.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 585 units.Note, the date of event is considered to be a best estimate as 27-jan-2025 based on the date of awareness.H11: this supplemental mdr is submitted to document the sample evaluation results and correct the product details.Visual evaluation of the product package finds there is puncture / impact damage to the outer product carton.The puncture continues into the tyvek pouch and tyvek envelope breaching the sterile barrier.There is also a visible crack in the mesh blister tray where the impact/ puncture occurred.At some point in transit the carton was impacted resulting in the damage found while in transit to user facility.This is the result of the product carton not being shipped in a protective outer shipper by the 3rd party carrier.No manufacturing anomalies were found.Updated fields: b4, b5, d9, g3, g6, h2, h6, h10, h11 corrected fields: d1 (medical device brand name), d4 (medical device catalog, medical device lot, medical device expiration date, unique identifier (udi)), g4 (pma / 510(k)#), h4 (device manufacture date) 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, when received the galaflex 3dr mesh box was found to be damaged and the internal wrapper of the mesh packaging was also breached which compromised the sterility.The mesh was not used and there was no patient involvement.Addendum: it was reported, the box was damaged with a cut in the box and the inner sterile packaging was also damaged.

• Brand Name: GALAFLEX 3D
• 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: 21413201
• Report Number: 1213643-2025-00065
• Device Sequence Number: 20912079
• Product Code: OOD
• UDI-Device Identifier: 00810054980261
• UDI-Public: (01)00810054980261(17)261024(10)LXHQ0011
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 100042-01
• Device Catalogue Number: SH3D01
• Device Lot Number: LXHQ0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 03/01/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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: Unknown