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

Catalog Number UNKAA053

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hematoma (1884); Seroma (2069); Hernia (2240); Neuralgia (4413)

Event Date 09/01/2009

Event Type  Injury  

Event Description

Per journal article: attachment of prosthetic mesh in open inguinal hernioplasty: suture vs.Synthetic glue.2011.Purpose: the purpose of this study is to compare the short and medium-term results of glue and conventional sutures in the attachment of prostheses in open inguinal hernioplasty with a plug and patch technique.Conclusion: synthetic glues based on cyanoacrylate may be used for mesh fixation in inguinal hernioplasty without risk of mesh migration or of high rates of recurrence.While their use does involve a lower incidence of chronic pain, more studies are needed to determine the different factors that may have an effect on the development of this pain, such as the age of the patient, the presence of preoperative pain and the weight of the mesh.Between sep, 2009 and may, 2011, 198 patients underwent inguinal hernioplasty; implanted with perfix plug and as fixated with cyanoacrylate glue or sutures.Postoperative complications included seroma (accumulation or drainage of serous-looking fluid in 17 patients), hematoma (accumulation or drainage of blood in 13 patients), post-op pain/chronic neuralgia (in 33 patients, post-op pain was managed by nsaids), hernia recurrence (1 patient) requiring reoperation due to recurrence in the pubic tubercle area.Ultrasound of the inguinocrural region was performed to confirm hernia recurrence.The article does not include specific case details or identify product catalog/lot numbers.

Manufacturer Narrative

Based on the information available, no conclusions can be made.The information provided is limited to the journal article.Hernia recurrence, seroma, and hematoma are known inherent risks of surgery/use of the device and are included as possible complications in the adverse reactions section of the instructions-for-use, supplied with the device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is provided as an estimate ((b)(6) 2009) based on the information provided.Device not returned.

• 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: 16384759
• MDR Text Key: 309638370
• Report Number: 1213643-2023-00050
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/31/2023

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