MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 GALAFLEX 3DR; BREAST - ABSORBABLE MESH

Model Number	100043-04
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Neuralgia (4413); Breast Discomfort/Pain (4504)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of galaflex 3dr the patient had experienced constant pain, discomfort, pinching sensation and also and felt like the galaflex implant was folded.The treating physician stated, "its "normal" and refuses to take it out and has told the patient to wait for it to absorb." based on the information provided, the degree to which the galaflex 3dr implant used 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 pain as a possible complication.A review of manufacturing records was performed and found that the device was manufactured to specification.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 bilateral breast reduction surgery the patient was implanted with galaflex 3dr on (b)(6) 2024.Reportedly, post one (1) week of implantation, the patient reported pain and pinching sensation and felt like the galaflex was folded over.The patient has been experiencing constant pain on the left breast with positioning since implant, also reported it almost feels like the galaflex is pinching a nerve.As reported the right breast is not as painful but does ache from time to time and the outline of the galaflex can be felt.The treating physician stated, "its "normal" and refuses to take it out and has told the patient to wait for it to absorb." the patient is having a breast mri on (b)(6) 2026 for routine breast cancer screening.

• Brand Name: GALAFLEX 3DR
• 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): 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: 25447556
• Report Number: 1213643-2026-00735
• Device Sequence Number: 18530919
• Product Code: OOD
• UDI-Device Identifier: 00810054980032
• UDI-Public: (01)00810054980032(17)261219(10)LXHS0030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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 Model Number: 100043-04
• Device Catalogue Number: FR3D04
• Device Lot Number: LXHS0030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2023
• 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 Age: 69 YR
• Patient Sex: Female