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

Catalog Number	5954790
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was discarded by the user facility, therefore we are unable to perform an evaluation.Based on the information provided the surgeon hydrated the mesh for 5-7 seconds.Per the instructions-for-use the mesh should be hydrated for no more that 1-3 seconds.The surgeon stated that the mesh was not over hydrated, however the sample was not provided for evaluation and it is unclear if this may have contributed to the alleged hydrogel separation.At this time no definitive conclusion can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.No manufacturing issues associated to the reported event were found in the reviewed lot.Dhr review showed all components for the lot met the specifications and there was no rework or other manufacturing abnormalities that may have contributed to this complaint.The information provided by bard 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 bard.Not returned.
Event or Problem Description
It was reported that while placing a bdi surgery / davol ventralight st mesh in the patient during a laparoscopic ventral hernia repair case the "sepra barrier (hydrogel) came off in chunks." as reported the surgeon hydrated the mesh for 5 - 7 seconds in sterile, room temperature saline and introduced the mesh through a skin incision.The surgeon reports that the mesh was not over hydrated.The mesh was removed and discarded.The case was completed with another ventralight st mesh.The surgeon has used this product for several years, and is familiar with the technology and technique.There was no patient injury.

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7491861
• Report Number: 1213643-2018-01357
• Device Sequence Number: 1417215
• Product Code: FTL
• UDI-Device Identifier: 00801741031663
• UDI-Public: (01)00801741031663
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 5954790
• Device Lot Number: HUCN1778
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1