MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SEPRAMESH IP; SURGICAL MESH

Catalog Number	5959480
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2018- patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of kugel patch (device 1).Per op notes, ¿the hernia sac was identified in left inguinal region and was reduced.A kugel patch (device 1) was placed into preperitoneal space and was sutured¿.(b)(6) 2018- patient was diagnosed with recurrent left inguinal hernia, thereby underwent open repair with partial explant of kugel patch (device 1), implant of sepramesh ip (device 2).Per op notes, ¿a hernia sac was identified in the left inguinal region and was dissected.The previously placed mesh was identified and noted to be medially separated from cooper¿s ligament and the pubic tubercle.The kugel patch (device 1) was trimmed medially and a sepramesh ip (device 2) was inserted into abdominal space and tacked¿.(b)(6) 2019 to (b)(6) 2019- patient had bilateral leg pain due to compressed nerve as a result of mesh migration.
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jan-2017) and date of event (15-jul-2019) are considered to be a best estimate.This emdr represents the sepramesh ip (device 2).An additional supplemental emdr was submitted to represent the kugel patch (device 1).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: SEPRAMESH IP
• Common Device Name: SURGICAL 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: 25334090
• Report Number: 1213643-2026-00693
• Device Sequence Number: 9981462
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816(17)190128(10)HUBN0059
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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 Expiration Date: 01/28/2019
• Device Catalogue Number: 5959480
• Device Lot Number: HUBN0059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2017
• 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: 51 YR
• Patient Sex: Male