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

Model Number	100042-02
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971)
Date of Event	04/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.As reported, the patient experienced post-op complications of necrosis and infection.Medical affairs has assessed the patient¿s postoperative course as being serious and likely related to the study device.Review of the device history records confirms the device was manufactured to specification.Infection is a known inherent risk of surgery/use of the device and is included as a possible complication in the adverse reaction section of the instructions-for-use (ifu).In regards to the 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." note: this mdr report is related to a retrospective study conducted to proactively gather real-world evidence on the use and safety of the p4hb product family, including galaflex scaffold, galaflex 3d, and galaflex 3dr.All safety events from the study are adjudicated by the bd medical monitor for an independent assessment of severity and relatedness.In an abundance of caution, events for which relatedness cannot be ruled out are processed for mdr reporting.
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2017, patient underwent bilateral revision augmentation mastopexy using a full vertical and horizontal t incision.2 pieces of galashape (galaflex 3d) were used (lot #160484).Concomitant procedures included: fat grafting to face, upper/lower blepharoplasty and excision of mid chest skin lesion.On (b)(6) 2017, left breast necrosis was reported.Patient had left breast debridement on (b)(6) 2017.Galaflex became exposed both visual and palpable at medial portion of left breast.Patient also was treated with medication (silvadene, carrington wound gel, unnamed antibiotic).On (b)(6) 2017, patient had local closure of left breast wound and wound vacuum application.Patient had another p4hb procedure on (b)(6) 2018 - revision left breast capsulectomy with wound debridement and closure and implant exchange, for full thickness tissue loss and infection of left breast.Patient on an antibiotic for sinus infection.Portions of original p4hb resected.Drain placement.2 pieces of galashape (lot # unknown) were used in this procedure.Resolved with sequelae on (b)(6) 2018.Review by medical affairs identifies the reported necrosis is likely related to the device and serious.

• 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: 15713685
• Report Number: 1213643-2022-00692
• Device Sequence Number: 6656443
• Product Code: OOD
• UDI-Device Identifier: 00855920006157
• UDI-Public: (01)00855920006157
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: 07/07/2017
• Device Model Number: 100042-02
• Device Catalogue Number: SH3D02
• Device Lot Number: 160484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 54 KG