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

Catalog Number 0113360

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Bacterial Infection (1735)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

Based on the information obtained, no conclusion can be made.Postoperative infection is a known inherent risk of surgery.The instructions-for-use (ifu) supplied with the device identifies infection as a possible complication.In regards to infection, the warnings section of the ifu states, "if an infection develops, treat the infection aggressively.An unresolved infection may not have to be removed.An unresolved infection, however, may require removal of the prosthesis." without a lot number, review of the manufacturing records cannot be conducted.Note, the date of event is estimated as (b)(6) 2016 based on the information available.Not returned.

Event Description

Per journal article surgical case report 2019 :"mesh removal and reconstruction with posterior components separation technique for delayed mesh infection developed 10 years after abdominal incisional hernia repair: a rare case report": a (b)(6) year-old man, who underwent reconstruction of abdominal incisional hernia by retroperitoneal bard/davol composix mesh application 10 years prior, developed 12 × 6.0 × 2.5 cm subcutaneous abscess followed by (b)(6) related mesh infection.The operation was performed excising the abscess wall (and mesh) without damaging peritoneum, and huge intermuscular defect was successfully reconstructed by posterior components separation technique application.

• Brand Name: MESH ¿ COMPOSIX
• 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: 13093482
• MDR Text Key: 282815437
• Report Number: 1213643-2021-20480
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0113360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 72 KG