MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 CAPSURE; STAPLE, IMPLANTABLE

Catalog Number	0113230
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
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-mar-2018) is considered to be a best estimate.This emdr represents the capsure straight (device 2).An additional supplemental emdr was submitted to represent the ventralight st (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.
Event or Problem Description
Per information provided: on (b)(6) 2019 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with implant of ventralight st (device 1) and capsure straight (device 2).Per op notes, ¿the hernia sac was noted with scarred up omentum.The omentum was reduced.The incarcerated fat was reduced.Some fat was excised and removed.A ventralight st mesh (device 1) was placed and secured using prolene sutures.The mesh was then tacked circumferentially using capsure straight (device 2) tacks.¿ on (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia and abdominal pain secondary to fixation device thereby underwent open repair with excision of ventralight st (device 1), capsure straight (device 2) and implant of biological mesh.Per op notes, ¿the devitalized skin and subcutaneous tissues in the midline was excised.The hernia sac was identified and opened.Adhesions of omentum to anterior abdominal wall were taken down.The previous mesh (device 1) was noted and excised along with capsure straight (device 2) tacks.The hernia sac was excised and removed.Myofascial flaps were raised bilaterally.A biological mesh was placed and sutured.¿.

• Brand Name: CAPSURE
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 25706950
• Report Number: 1213643-2026-00853
• Device Sequence Number: 18787042
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996(17)200328(10)HUCQ1954
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: 03/28/2020
• Device Catalogue Number: 0113230
• Device Lot Number: HUCQ1954
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2018
• 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: 58 YR
• Patient Sex: Male