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

Catalog Number	5991015
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date, this is the only reported complaint for this manufacturing lot of 185 units released for distribution in (b)(6) 2020.A review of the manufacturing records was performed and found that the lot was manufactured to specification.When the investigation has been completed, a supplemental mdr will be submitted.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, during a surgical procedure on (b)(6) 2021, the surgeon opened a bard/davol ventralight st mesh w/ echo ps 2 and noted that the mesh had "unraveled.The procedure was completed using another mesh.There was no reported patient injury.
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in september, 2020.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of device evaluation.Visual evaluation of the returned sample indicates the mesh is unused, and has not been handled with excessive force or rolled for attempted placement into the patient.The echo 2 frame for product code 5991015 is connected to the mesh with four (4) connectors.As received, all four (4) of the connectors are present on the frame, but only two (2) are attached to the mesh.Holes in the mesh, from the connectors, indicate that the two detached connectors were at one point connected to the mesh.Based on the event as reported (out of box), sample evaluation and investigation performed, the most likely root cause of the connector detachment is the event occurred due to handling of unit during the manufacturing process.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 : sample evaluated.
Event or Problem Description
As reported, during a surgical procedure on (b)(6) 2021, the surgeon opened a bard/davol ventralight st mesh w/ echo ps 2 and noted that the mesh had "unraveled.The procedure was completed using another mesh.There was no reported patient injury.

• 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
• MDR Report Key: 11396317
• Report Number: 1213643-2021-20046
• Device Sequence Number: 19124080
• Product Code: FTL
• UDI-Device Identifier: 00801741130984
• UDI-Public: (01)00801741130984
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 06/28/2021
• Device Catalogue Number: 5991015
• Device Lot Number: HUEU1729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other