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

Model Number	100035-09
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, patient was implanted with galaflex on (b)(6) 2020.On (b)(6) 2020 patient was diagnosed with left breast infection.Note: subject had gel foam used with lotus (b)(6)2020: 4mm incision found open at the t and leaking tea-colored fluid.No significant volume drained, but irrigated with antibiotic solution.Drain placed and positive culture/sensitivity.As reported, the treating surgeon identified the condition of the infection as not caused by the galaflex (p4hb) implant used to treat the patient.
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a post-op complication of breast infection.Infection is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reaction section of the ifu.In regards to infection, the warnings section of the ifu states, "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." the surgeon did not identify any causal relationship between the post-op complication 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.Not returned-remains implanted.
Event or Problem Description
As reported, patient was implanted with galaflex on (b)(6) 2020 and was diagnosed with left breast infection on (b)(6) 2020.Note: subject had gel foam used with lotus (b)(6) 2020: 4mm incision found open at the t and leaking tea-colored fluid.No significant volume drained, but irrigated with antibiotic solution.Drain placed and positive culture/sensitivity.As reported, the treating surgeon identified the condition of the infection as not caused by the use of the p4hb implant to treat the patient.The complaint was entered to document the complication.
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a post-op complication of breast infection.Infection is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reaction section of the ifu.In regards to infection, the warnings section of the ifu states, "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." the surgeon did not identify any causal relationship between the post-op complication 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.Addendum: h11: this is an addendum to the initial mdr submitted (1213643-2022-00600).This supplemental mdr is submitted to report the corrected implan 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, patient was implanted with galaflex on (b)(6)2020 and was diagnosed with left breast infection on (b)(6) 2020.Note: subject had gel foam used with lotus (b)(6) 2020: 4mm incision found open at the t and leaking tea-colored fluid.No significant volume drained but irrigated with antibiotic solution.Drain placed and positive culture/sensitivity.As reported, the treating surgeon identified the condition of the infection as not caused by the use of the p4hb implant to treat the patient.The complaint was entered to document the complication.
Additional Manufacturer Narrative
As reported, the patient was diagnosed with a post-op complication of breast infection.Infection is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reaction section of the ifu.In regards to infection, the warnings section of the ifu states, "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." the surgeon did not identify any causal relationship between the post-op complication 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.Addendum #1: h11: this is an addendum to the initial mdr submitted (1213643-2022-00600).This supplemental mdr is submitted to report the corrected implant date in describe event or problem (b5).Updated field: b4, g3, g6, h2, h10, h11.Corrected field: b5 (describe event or problem).Addendum #2: h11: this supplemental mdr is submitted to correct medical device manufacturer and udi.Updated fields: b4, g3, g6, h2, h10, h11.Corrected fields: d3 (medical device manufacturer) and d4 (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.

• Brand Name: GALAFLEX
• Common Device Name: BREAST - 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: 15326343
• Report Number: 1213643-2022-00600
• Device Sequence Number: 14737755
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041(17)220531(10)200330
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 05/31/2022
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: 200330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 09/28/2022; 09/03/2024
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/30/2022; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2020
• 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 Age: 50 YR
• Patient Sex: Female