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

Catalog Number UNKAA053

Device Problems Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problems Fistula (1862); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 07/01/1999

Event Type  Injury  

Manufacturer Narrative

Based on the information available, no conclusions can be made.The information obtained is limited to the article.As reported, patients experienced postoperative complications of hernia recurrence, wound infection, and fistula.Additionally, the article states that in one case of recurrence, upon reoperation the mesh was found to be curled.However, states that the mesh was not placed smoothly during implant.Hernia recurrence and fistula are included as possible complications in the adverse reactions section of the instructions-for-use (ifu), supplied with the device.In regard to infection, the warnings section in ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device".No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event ((b)(6) 1999) is provided as an estimate based on the information provided.Not returned.

Event Description

Per journal article: tension-free mesh-plug hernioplasty in treating inguinal hernia - lingnan modern clinics in surgery, mar.2003, vol.3 no.1.Purpose: to investigate the advantages of polypropylene mesh-plug and patch in inguinal hernioplasty and to summarize and study the operation time, wound pain, post-operative autonomous ability recovery, complications and recurrence rate.Conclusion: perfix plug has good tissue-compatibility, capability of anti-infection and no rejection.It is ideal material for hernia repair.The mesh & plug lesion-free hernia repair is easy to be performed and it has an advantage of minor trauma, quicker recovery and lower recurrence.And the operation indication can be widened.It is one of the most advanced methods in the treatment of the groin hernia.As reported per journal article, 108 patients underwent tension-free hernioplasty from jul-1999 to oct-2001 and were implanted with perfix plug.Post operative complications included: wound infection (2 patients) and one of them recovered through incision and drainage without removing the patch.A case developed chronic non-healing fistula, & mesh removal.There were 2 cases of recurrences in this group, and 1 of them found during reoperation that the patch was not placed smoothly and curled.The article does not include specific case details or identify product catalog/lot numbers.

• 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: 16384767
• MDR Text Key: 309638227
• Report Number: 1213643-2023-00049
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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