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

Catalog Number	5990015
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the events as reported and not having the sample returned for evaluation, no conclusion can be made.There was no reported additional surgical intervention taken to locate the missing connector.Multiple attempts have been made to obtain additional information with no response from the contacts.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of (b)(4) released for distribution in may, 2018.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2019 following an unspecified procedure using a bard ventralight st w/ echo 2 ps a count was taken and the echo ps was noted to be missing one of the seven (7) mesh to frame connecters.As reported a count of seven (7) was made prior to the procedure and at the end of the procedure they only accounted for six (6).There was no patient injury reported.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8286300
• Report Number: 1213643-2019-00521
• Device Sequence Number: 1991673
• Product Code: FTL
• UDI-Device Identifier: 00801741130991
• UDI-Public: (01)00801741130991
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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: 04/28/2019
• Device Catalogue Number: 5990015
• Device Lot Number: HUCR0309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1