MAUDE Adverse Event Report: COVIDIEN SYMBOTEX MESH 20CM; MESH, SURGICAL, POLYMERIC

Catalog Number SYM20

Device Problem Material Puncture/Hole (1504)

Patient Problems Pain (1994); Hernia (2240)

Event Date 03/11/2019

Event Type  Injury  

Event Description

Pt had hernia repair with mesh (b)(6) 2017 and was admitted (b)(6) 2019 due to recurrent incisional hernia and pain.He was taken for a laparoscopic repair on (b)(6) 2019 and it was noted during surgery that the mesh was intact circumferentially with "a hole blown right out of the middle" and a significant amount of exudate in the hernia sac and with concern for bacterial translocation.A primary repair of the hernia was performed.

• Brand Name: SYMBOTEX MESH 20CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8432789
• MDR Text Key: 139346565
• Report Number: MW5085004
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: SYM20
• Device Lot Number: PQG0177X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 108