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

Catalog Number	0117010
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Seroma (2069); Urinary Retention (2119)
Date of Event	01/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the contents of the article, no conclusions can be made as to the degree to which the device may have caused or contributed to the reported patient postoperative conditions.The information obtained is limited to the article.Seroma formation is a known inherent risk of surgery.The adverse reaction section of the instructions-for-use, supplied with the device lists seroma as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (01-jan-2013) is considered to be a best estimate.Note: section a through f - 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.
Event or Problem Description
Per journal article: "comparison of open preperitoneal and transabdominal preperitoneal hernia repair for primary unilateral femoral hernia" this article is a retrospective study of comparison of the outcomes of open and laparoscopic surgical femoral hernia (fh) treatment.A total of 132 patients with primary unilateral femoral hernia (fh) were recruited for this study in which 62 patients underwent open surgery (os) and 70 patients underwent transabdominal preperitoneal (tapp) procedure in beijing chao-yang hospital from january 2013 to june 2018.As reported, 10 cm x 10 cm non-bd mesh (62 patients) was implanted in os group, whereas 10 cm × 15 cm bard soft mesh (43 patients) and non-bd mesh (27 patients) were implanted and fixated with medical glue in tapp group.Follow-up review was conducted at 1, 3, 6 and 12 months postoperatively.Post implant of bard soft mesh in the tapp group had complications of vessel injury (1), seroma (5) and urinary retention (1).Seroma is the most frequent observed complication in patients who underwent tapp repair and all seromas resolved well with conservative treatment within 2 months.The overall complication rates were equivalent between the os and tapp groups.There were no cases of recurrence in either group.It was concluded that both laparoscopic and open surgery appear to be safe and effective in a cohort of patients with femoral hernia and laparoscopic surgery might offer some advantages in reducing length of hospital stay, lower postoperative pain score and quicker return to activities.

• Brand Name: BARD SOFT MESH
• Common Device Name: 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: 20464609
• Report Number: 1213643-2024-00502
• Device Sequence Number: 20992235
• Product Code: FTL
• UDI-Device Identifier: 00801741030871
• UDI-Public: (01)00801741030871
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2024

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 Catalogue Number: 0117010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown