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 Wound Dehiscence (1154); Hematoma (1884); Swelling/ Edema (4577)

Event Date 02/01/2002

Event Type  Injury  

Event Description

Per journal article: "comparison of three types of hernia repair surgeries using meshes for adult inguinal hernia: lichtenstein, mesh-plug, prolene hernia system" 2009.Purpose: the aim of this study was to compare three types of hernioplasty using a mesh: lichtenstein, mesh-plug and prolene hernia system.Conclusion: this study compared three types of hernia repair surgeries using meshes that are common today.Although the age, gender, surgery time, admission period, amount of post-operative pain medication use, complications, recurrence, and other factors were compared among the three surgical methods, no significant differences existed.Therefore, it is difficult to assess which surgical method is best, based on the results of this study alone.As reported, from february 2002 to april 2007, total 138 inguinal hernia repairs performed with implant of three types of meshes namely, bard/davol marlex (bard flat mesh) (18), perfix plug (38) and non-bard prolene mesh (82).In terms of surgery-related complications; 1 case of wound infection, 1 case of testicular edema in the lr group (marlex).3 hematoma, 1 wound dehiscence, 2 testicular edema in the mr group (perfix plug).5 hematoma and 3 testicular edema in the phs group (prolene).There were no instances of systemic complications or severe complications beyond complications at the surgical wound due to the hernia repair.There was no hernia recurrence.This file represents the perfix plug.

Manufacturer Narrative

Based on the information available, no conclusions can be made.The information obtained is limited to the article.As reported, patient experienced the post-op complications of hematoma, wound dehiscence, and testicular edema.Hematoma is known inherent risks of surgery/use of the device and is included as possible complication 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 ((b)(6) 2002) is provided as an estimate based on the information provided.This mdr represents the perfix plug.An additional mdr was submitted to represent the marlex mesh (bard flat mesh).The information provided by bd 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 bd.

• 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: 16395368
• MDR Text Key: 309892355
• Report Number: 1213643-2023-00052
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/02/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/17/2023
• 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