MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 GALAFLEX LITE; BREAST - ABSORBABLE MESH

Catalog Number	GFLT0019BD
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Necrosis (1971)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient experienced erythema observed on the left breast and along with mild necrosis post implant of galaflex lite.It was also reported that the patient is currently under close clinical monitoring and continued observation.However, no causal relationship between galaflex lite and the reported clinical findings has been identified or suspected by the treating physician.Based on the information provided the degree to which the galaflex lite implant used to treat the patient, may have caused or contributed to the patient's postoperative course is unknown.The adverse reaction section of the instructions-for-use, supplied with the device identifies erythema as possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (22-jan-2026) is considered to be the best estimate based on the date of awareness.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 left mastectomy reconstruction on (b)(6) 2025 using galaflex lite, post implant of the mesh the patient experienced erythema observed on the left breast and along with mild necrosis.It was also reported that as per the clinical assessment, the finding is unlikely to be related to the use of galaflex lite.The patient is currently under close clinical monitoring and continued observation.Additionally, the erythema is absent when the patient is in a supine position.

• Brand Name: GALAFLEX LITE
• Common Device Name: BREAST - ABSORBABLE MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 24331434
• Report Number: 1213643-2026-00128
• Device Sequence Number: 15900310
• Product Code: OOD
• UDI-Device Identifier: 00801741233814
• UDI-Public: (01)00801741233814
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K233999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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 Catalogue Number: GFLT0019BD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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