MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX LIGHT PLUG; SURGICAL MESH

Catalog Number	0117060
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample evaluation finds visible contamination (blood stain) and physical manipulation of the device which is expected of a mesh that was used during an attempted implantation.Per the sample evaluation a portion of the mesh plug was torn but still partially attached.Visual examination of the mesh material shows it to be visibly stretched and appears to have been grasped and pulled on.It appears that forces applied during attempted implantation by the user caused a portion of the inner pedal to tear.The problem appears to have presented prior to securing the implant with suture.No manufacturing anomalies were identified and this appears to be a use of device issue.To date there have been no other complaints reported for this manufacturing lot of (b)(4) units released for distribution in january, 2017.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.
Event or Problem Description
The following was reported to davol: it was reported that the bard/davol perfix light plug "opened" inadvertently during right inguinal hernia repair surgery and the mesh partially tore off.Another mesh was implanted to complete the case.There was no injury to the patient.

• Brand Name: PERFIX LIGHT PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7060848
• Report Number: 1213643-2017-00926
• Device Sequence Number: 1287962
• Product Code: FTL
• UDI-Device Identifier: 00801741030956
• UDI-Public: (01)00801741030956
• Combination Product (Y/N): N
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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: 11/28/2021
• Device Catalogue Number: 0117060
• Device Lot Number: HUAY2692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1