MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH

Catalog Number 5954810

Device Problem Obstruction of Flow (2423)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Discomfort (2330); Obstruction/Occlusion (2422)

Event Date 01/28/2015

Event Type  Injury  

Event Description

The following was reported to davol: on (b)(6) 2014 - pt underwent open repair of a giant ventral hernia; in 2014 - pt experienced abdominal discomfort, which was managed with diet change; on (b)(6) 2014 - pt's discomfort progressed and the pt was hospitalized, and after a few days of zero regime, the problem improved.Ct scan suggests mesh adhesions; on (b)(6) 2015 - pt presented with intestinal obstruction and underwent explant of the mesh.The mesh was reported to have been in good position.It was reported that the mesh presented adhesions and was removed.

Manufacturer Narrative

Based on the info provided we are unable to determine to what extent, if any, the bard device may have caused or contributed to the event as alleged.As reported that the mesh was placed correctly, with the polypropylene side outward and the hydrogel side toward the intestine.The possibility of adhesion formation is a known adverse event listed in the ifu.Additionally, the ifu prescribes the proper method of implantation of the device to prevent undue injury to the pt and damage to the product.The sample was discarded by the user facility, and unavailable for evaluation.A review of the manufacturing records shows that the lot was manufactured to specification this mdr incudes all pt, event and device info davol has received to date.If additional info is obtained, a follow up mdr will be submitted.

• Brand Name: VENTRALIGHT ST MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; lot #1, road #3, km 79.7; san geronimo industrial park; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvdg; warwick, RI 02886 ; 8005566756
• MDR Report Key: 4561875
• MDR Text Key: 20151050
• Report Number: 1213643-2015-00043
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 5954810
• Device Lot Number: HUXG0048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 78