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

Catalog Number	0112780
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	01/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-aug-2013) is considered to be a best estimate.This emdr represents the bard/davol perfix plug (device 2).An additional supplemental emdr was submitted to represent the bard/davol perfix plug (device 1).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 information provided: (b)(6) 2014 - patient was diagnosed with indirect and direct right scrotal hernia thereby underwent open repair with implant of perfix plugs (device 1 and 2).Per op notes, ¿right scrotal sac was identified, and the contents were partially reduced.Two-thirds of his small bowel was noted in the right scrotal sac and reduced back into peritoneal cavity.Separate hernia sacs were identified involving the right colon and excised.Two perfix plugs (device 1 and 2) were placed into the defect and secured with sutures.¿ (b)(6) 2017 - patient was diagnosed with recurrent incarcerated right inguinal hernia thereby underwent open repair with excision of perfix plugs (device 1 and 2).Per op notes, ¿a scar from previous hernia repair was identified in the right groin region.A large, indurated mass consistent with the previous plugs (device 1 and 2) were noted in the inguinal canal.The hernia sac was reduced, and the plugs (device 1 and 2) were excised completely, and hernia was repaired with sutures.¿.

• Brand Name: PERFIX PLUG
• 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: 23836379
• Report Number: 1213643-2025-01240
• Device Sequence Number: 9278211
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622(17)180928(10)HUXH1690
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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 Expiration Date: 09/28/2018
• Device Catalogue Number: 0112780
• Device Lot Number: HUXH1690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2013
• 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 Age: 50 YR
• Patient Sex: Male