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

Model Number	100035-09
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Breast Mass (2439)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent breast reconstruction procedure on (b)(6) 2017 and was implanted with galaflex.It was reported that about 5-6 years later, the patient with galaflex (p4hb) implant may have a breast cancer recurrence.It was also reported that the patient is currently undergoing diagnostic testing to confirm possible cancer recurrence.
Additional Manufacturer Narrative
As reported, the patient may possibly have a breast cancer recurrence post implant of galaflex (p4hb).Based on the information available, no conclusions can be made.There is no identified causal relationship between the possible cancer recurrence and the galaflex implant used to treat the patient.In an abundance of caution, events for which relatedness cannot be completely ruled out are processed for mdr reporting.Review of manufacturing records shows product was manufactured to specification.Note, the date of event is considered to be a best estimate as ((b)(6) 2022) based on the awareness date.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.Not returned.
Additional Manufacturer Narrative
As reported, the patient may possibly have a breast cancer recurrence post implant of galaflex (p4hb).Based on the information available, no conclusions can be made.There is no identified causal relationship between the possible cancer recurrence and the galaflex implant used to treat the patient.In an abundance of caution, events for which relatedness cannot be completely ruled out are processed for mdr reporting.Review of manufacturing records shows product was manufactured to specification.Note, the date of event is considered to be a best estimate as (12-dec-2022) based on the awareness date.Addendum: h11: this supplemental mdr is submitted to correct medical device manufacturer and udi.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, the patient underwent breast reconstruction procedure on (b)(6) 2017 and was implanted with galaflex.It was reported that about 5-6 years later, the patient with galaflex (p4hb) implant may have a breast cancer recurrence.It was also reported that the patient is currently undergoing diagnostic testing to confirm possible cancer recurrence.

• 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; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 16034987
• Report Number: 1213643-2022-00815
• Device Sequence Number: 5476562
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041(17)200331(10)170308
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: 170308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2017
• 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: Required Intervention
• Patient Sex: Female