MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5991520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Gastrointestinal Problem (4491)
Date of Event	09/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of ventralight st mesh (echo 2) the patient presented with abdominal pain and was diagnosed with a small bowel adhesion and ileus.Based on the information provided, no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Pain and adhesion are known inherent risks of surgery/use of device and are included as possible complications in the adverse reaction section of the instructions-for-use, supplied with the device.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, the patient underwent a ventral incisional hernia repair procedure on (b)(6) 2022, during which a bard/davol ventralight st w/echo 2 was used to treat the patient.On (b)(6) 2022, the patient presented with abdominal pain, and underwent a ct scan.The ct examination revealed mesh adhesion of the small intestine and a diagnosis of ileus on the right side.On (b)(6) 2022, the doctor decided to follow up with an ileus tube.As reported, it is not known whether the adhesion was due to the rolling of the mesh, adhesion to the mesh coating, or if the mesh was the cause.The patient did not undergo additional surgical intervention due to this reported event.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 15461267
• Report Number: 1213643-2022-00625
• Device Sequence Number: 19901988
• Product Code: FTL
• UDI-Device Identifier: 00801741131004
• UDI-Public: (01)00801741131004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2022

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 Catalogue Number: 5991520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/21/2022
• 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 Sex: Male