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

Model Number	100035-09
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a pin hole was noted in the galaflex sterile package.Based on the sample evaluation the packaging did not have any holes or voids in the sterile barrier which remained intact.While opening a small tear in one of the foil packaging layers presented in the crease created.A penetration test showed that the integrity of the package is intact.The condition of creasing, dimples presenting when the foil pouch is opened is a known anticipated material characteristic of foil packaging.Review of manufacturing records confirms product was manufactured to specification.Note, the date of event is considered to be a best estimate as (b)(6) 2023 based on the date of awareness.
Event or Problem Description
As reported, upon opening the product package of galaflex, there was a small pin hole noted in the sterile envelope.It was reported that the mesh was not used and was discarded.It was also reported that another mesh piece was used and there was no reported patient injury.
Additional Manufacturer Narrative
As reported, a pin hole was noted in the galaflex sterile package.Based on the sample evaluation the packaging did not have any holes or voids in the sterile barrier which remained intact.While opening a small tear in one of the foil packaging layers presented in the crease created.A penetration test showed that the integrity of the package is intact.The condition of creasing, dimples presenting when the foil pouch is opened is a known anticipated material characteristic of foil packaging.Review of manufacturing records confirms product was manufactured to specification.Note, the date of event is considered to be a best estimate as 15-feb-2023 based on the date of awareness.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the manufacturing location which was inadvertently incorrectly updated in the initial mdr.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.H3 other text : sample evaluated.
Event or Problem Description
As reported, upon opening the product package of galaflex, there was a small pin hole noted in the sterile envelope.It was reported that the mesh was not used and was discarded.It was also reported that another mesh piece was used and there was no reported patient injury.

• Brand Name: GALAFLEX
• 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; lot #1, road #3, km 79.7; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 16523420
• Report Number: 1213643-2023-00084
• Device Sequence Number: 2343292
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• 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,Followup
• Report Date (Section B): 03/23/2023

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 Expiration Date: 11/30/2023
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: 210476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 04/01/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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