MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MODIFIED KUGEL PATCH; SURGICAL MESH

Catalog Number	0115808
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Prolapse (2475)
Date of Event	02/18/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information as reported, no conclusion can be made as to why the mesh allegedly "prolapsed into the inguinal canal." while no conclusion can be made regarding the possible cause of the alleged "prolapse" the instructions-for-use prescribe the proper method of fixating the mesh in position.The information provided to date is limited, additional information has been requested.Should additional information be provided, a supplemental emdr will be submitted.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.Remains implanted.
Event or Problem Description
The following was reported via (b)(6).It was reported that on (b)(6) 2010 the patient was implanted with a davol modified kugel mesh.As reported the mesh has prolapsed into the inguinal canal.It is reported that the patient experiences daily searing, stabbing pain similar to "appendicitis attacks" that wakes her from sleep.It is reported that the pain affects the groin and down the inner thigh and the contact reports that "it makes my large toenail go dark blue/black when i sit for longer periods." as reported the patient takes pain medication and has completed two pain courses and she is awaiting further treatment from a pain specialist.It is reported that the patient is "considering removal surgery by a specialist which is very risky and damage to nerves and a chance of death occurring as well.".
Event or Problem Description
The following was reported via tga (therapeutic goods administration, dept.Of health, australia).It was reported that on (b)(6) 2010, the patient was implanted with a davol modified kugel mesh.As reported the mesh has prolapsed into the inguinal canal.It is reported that the patient experiences daily searing, stabbing pain similar to "appendicitis attacks" that wakes her from sleep.It is reported that the pain affects the groin and down the inner thigh and the contact reports that "it makes my large toenail go dark blue/black when i sit for longer periods." as reported the patient takes pain medication and has completed two pain courses and she is awaiting further treatment from a pain specialist.It is reported that the patient is "considering removal surgery by a specialist which is very risky and damage to nerves and a chance of death occurring as well.".
Additional Manufacturer Narrative
This is an addendum to document the completion of the manufacturing review and to make a correction to manufacturing date.The manufacturing records review found that the lot was manufactured to specification.Corrected field: device manufacture date updated fields: date of report, date rec¿d by mfr, pma/510k, if follow-up, what type.Should additional information be provided, a supplemental emdr will be submitted.

• Brand Name: MODIFIED KUGEL PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7529059
• Report Number: 1213643-2018-01588
• Device Sequence Number: 16568116
• Product Code: FTL
• UDI-Device Identifier: 00801741030789
• UDI-Public: (01)00801741030789
• Combination Product (Y/N): N
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2014
• Device Catalogue Number: 0115808
• Device Lot Number: HUTB1237
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: Required Intervention