MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG; SURGICAL MESH

Catalog Number 0112770

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Nerve Damage (1979); Pain (1994); Seroma (2069); Hernia (2240)

Event Date 08/18/2010

Event Type  Injury  

Manufacturer Narrative

Based on the available information, no conclusion can be made.Contact information was not provided, therefore, we are unable to request additional information.Seroma and recurrence are known inherent risks of hernia repair surgery and are listed in the adverse reactions section of the instructions-for-use (ifu) supplied with this device as possible complications.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in january, 2009.Should additional information be provided, a supplemental mdr will be submitted.Not returned - mesh explanted.

Event Description

The following was reported via tga report ((b)(6) fda): the tga report states, " recurrent left femoral hernia, large seroma directly post-surgery, and the prominent mesh plug (bard/davol perfix plug large) migrated resulting in surgery for removal.Drainage of 450-650ml seroma ¿ large volume of fluid.Seroma was drained by needle and syringe under ultra sound in hospital (b)(6) 2010.Permanent nerve damage to several nerves in the region.Onset of permanent ceaseless chronic pain ¿ chronic regional pain syndrome.Pain management plan - started receiving pain medication on a more permanent basis such as a nerve blocker (endep) and opioid (endone) on a regular to permanent basis.".

• Brand Name: PERFIX PLUG
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12432210
• MDR Text Key: 270087212
• Report Number: 1213643-2021-20307
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Catalogue Number: 0112770
• Device Lot Number: HUTA0015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention