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

Catalog Number	0116003
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol crurasoft patch on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against crurasoft patch.Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.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-aug-2011) is considered to be a best estimate.Updated fields: a2, b2, b3, b4, b5, b7, d3, d4 (product catalog no., udi no., corporate lot no., expiry date), g1, g3, g6, h2, h4, h6, h10.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.H3 other text: not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol crurasoft patch on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against crurasoft patch.Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with paraesophageal hernia thereby underwent laparoscopic repair with implant of crurasoft mesh.Per op notes, ¿the stomach was reduced.The hernia sac was identified and dissected free.A crurasoft mesh was placed in the left crus and sutured.¿ (b)(6) 2016 ¿ patient had pain and heartburn once a month.(b)(6) 2017 - patient was diagnosed with recurrent hiatal hernia thereby underwent laparoscopic repair with primary closure.Per op notes, ¿the adhesions of omentum and anterior proximal stomach was taken down.The prior mesh was firmly incorporated at the anterior aspect of diaphragmatic hiatus.The stomach was reduced.The hernia sac was identified and dissected free.The hernia was repaired with sutures.Fundoplication was performed.¿ (b)(6) 2018 - patient underwent open pyloroplasty (heineke-mikulicz), incisional biopsy of anterior peritoneal implant.(note: no operative notes provided for this procedure).

• Brand Name: CRURASOFT PATCH
• 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 ; 4018258495
• MDR Report Key: 10806699
• Report Number: 1213643-2020-10079
• Device Sequence Number: 3500688
• Product Code: FTL
• UDI-Device Identifier: 00801741030840
• UDI-Public: (01)00801741030840(17)160928(10)HUVH0783
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K022350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 09/28/2016
• Device Catalogue Number: 0116003
• Device Lot Number: HUVH0783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 11/08/2020
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2011
• 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: Disability; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 92 KG