MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP; SURGICAL MESH

Catalog Number	5959480
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.Per medical records review, about 2 months post implant of sepramesh ip, patient was diagnosed with adhesions and pelvic pain thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists adhesions and pain as possible complications.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
Per information provided by patient's attorney: (b)(6) 2021 - patient with history of pelvic prolapse, rectocele, erosion of previously implanted urethral mesh and vaginal mesh was diagnosed with dyspareunia thereby underwent robotic assisted laparoscopic rectopexy with the implant of sepramesh ip.Per operative notes, ¿prior colpopexy mesh and suburethral mesh slings were encountered and dissected.Rectopexy was performed using a trimmed sepramesh ip, which was introduced into the pelvic cavity and secured to the distal-most rectum using sutures.¿ (b)(6) 2021 - patient had lower abdomen tightness during hospital visit.Also, feels mesh near the anal opening and some bowel blockage.(b)(6) 2021 - patient was diagnosed with pelvic pain, pelvic floor dysfunction thereby underwent robotic assisted laparoscopy with the explant of sepramesh ip and a sigmoidoscopy.Per operative notes, ¿the small bowel was removed from the pelvis.The mesh was dissected superiorly and continued to inferiorly.All the sutures and mesh were removed completely.".

• Brand Name: SEPRAMESH IP
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 19474479
• Report Number: 1213643-2024-093063
• Device Sequence Number: 19842456
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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: 07/28/2022
• Device Catalogue Number: 5959480
• Device Lot Number: HUEU1105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 72 KG