MAUDE Adverse Event Report: DAVOL, A BARD COMPANY XENMATRIX SURGICAL GRAFT; SURGICAL MESH

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Bacterial Infection (1735); Fever (1858); Inflammation (1932); Test Result (2695)

Event Date 04/03/2018

Event Type  malfunction  

Event Description

This is a potential product problem.The patient is a (b)(6) year old former (b)(6) preterm infant; neonatal course complicated by necrotizing enterocolitis with bowel resection.Underwent multi-visceral transplant on (b)(6) 2015.Because of chronic rejection underwent second multi-visceral transplant on (b)(6) 2017 with placement of xenmatrix graft to repair abdominal incision site.The post-op course was complicated by intermittently positive blood culture: (b)(6) 2017 for microbacterium abscessus.Treated with 4-drug regimen: amikacin - s, imipenem - i, linezolid - i, and azithromycin - s for 8 weeks until (b)(6) 2018.Began having fever on (b)(6) 2018 with increasing inflammatory markers.There is a biopsy of an intra-abdominal mass adjacent to xenmatrix positive for acid-fast bacillus.

• Brand Name: XENMATRIX SURGICAL GRAFT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL, A BARD COMPANY; warwick RI 02886
• MDR Report Key: 7457569
• MDR Text Key: 106632849
• Report Number: MW5076678
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 18