MAUDE Adverse Event Report: C.R. BARD COMPOSIX MESH 6/8; HERNIA MESH

Catalog Number 0123680

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Fatigue (1849); Fever (1858); Flatus (1865); Nausea (1970); Pain (1994); Sleep Dysfunction (2517); Blood Loss (2597)

Event Date 10/22/2003

Event Type  Injury  

Event Description

Reporter stated she had fever for three days immediately after the mesh implant.The doctors could not determine the cause of the fever.For a year now she has been in a lot of pain, can barely stand, nausea, pain in pelvic area, difficulties breathing, painful sex, pain in back and can barely walk, usually very tired and cannot sleep.She stated that last month she coughed up blood.Her abdomen has been bulging for thirteen years now.She went back to the doctor to ask why she has the bulging abdomen and was told it was due to stretched skin.Reporter stated that mesh patch is holding in stomach contents.She states that when she moves it feels like something is moving and sliding inside her abdomen.

• Brand Name: COMPOSIX MESH 6/8
• Type of Device: HERNIA MESH
• Manufacturer (Section D): C.R. BARD
• MDR Report Key: 5949152
• MDR Text Key: 54766736
• Report Number: MW5064733
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 0123680
• Device Lot Number: 43DMD090
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 75