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

Model Number	100027-09
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	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, foreign material (hair) was found in the galaflex lite package.The sample is reported to be available for return however, has not been received at this time.Based on the information reported 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 597 units released for distribution in april 2023.Should the sample be returned for evaluation, a supplemental mdr will be submitted to document the results of the sample evaluation.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, it was found that there was a foreign material (hair) inside the galaflex lite package while opening the sterile packaging.There was no patient injury.
Additional Manufacturer Narrative
As reported, foreign material (hair) was found in the galaflex lite package.The sample is reported to be available for return however, has not been received at this time.Based on the information reported 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 released for distribution in april 2023.Should the sample be returned for evaluation, a supplemental mdr will be submitted to document the results of the sample evaluation.H11: this supplemental mdr is submitted to document the sample evaluation results.Evaluation of the returned sample confirms the foreign material (hair or fiber, black in color) presents itself on top of the inner sterile envelope on the backside.Based on the information provided and sample evaluation it was determined that most probable root cause for the hair to present in the packing is the result of improper gowning practices during the manufacturing process.An awareness training was performed with the appropriate personnel.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, it was found that there was a foreign material (hair) inside the galaflex lite package while opening the sterile packaging.There was no patient injury.

• Brand Name: GALAFLEX LITE
• 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: 19885953
• Report Number: 1213643-2024-00388
• Device Sequence Number: 7254659
• Product Code: OOD
• UDI-Device Identifier: 00810054980582
• UDI-Public: (01)00810054980582(17)250131(10)LXHP0015
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 08/02/2024

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 Expiration Date: 01/31/2025
• Device Model Number: 100027-09
• Device Catalogue Number: GFLT1520
• Device Lot Number: LXHP0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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