MAUDE Adverse Event Report: BARD MESH DOUBLE LAYER BARD MESH

Lot Number 43ELD238

Device Problems Device Emits Odor (1425); Extrusion (2934)

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Bacterial Infection (1735); Internal Organ Perforation (1987)

Event Date 08/30/2002

Event Type  Injury  

Event Description

I had a bilateral mastectomy with a tram flap reconstruction on (b)(6) 2002 and then 10-14 days later my dissolvable sutures started popping and the double layer bard mesh #43eld238 started surfacing.I saw the plastic surgeon and he had to debride the mesh.In (b)(6) i began chemotherapy treatment and after every treatment my abdomen would open and the mesh would surface with each chemo treatment.The abdominal wound eventually grew to approximately 8 inches in length and 3 inches in width.The mesh had to be debrided every few weeks and i would have to clean and pack the wound for 16 months.The plastic surgeon wanted the abdomen to heal from the inside out.I had returned to (b)(6) where i was living with my family.(i had returned to the united states to have my surgery and chemo treatments and then returned to (b)(6) where the embassy doctor would check on my open wound and then i would go back and see the plastic surgeon and oncologist during the summer of 2003.The plastic surgeon still had to debride the mesh that summer.After returning to (b)(6) the mesh kept surfacing and began smelling quite a bit and i had been sent to a few different (b)(6) doctors and they had no idea what to do with me.I developed (b)(6) and was sent to (b)(6) to see a plastic surgeon there and she was appalled that this had happened and i was allowed to have this wound exposed for such a long time.She had to cut a bit more of the mesh but was able to get all of it out and then closed the abdominal wound after 16 months.I still tend to have unusual pains in the abdomen area on occasion.I had a perforated colon in (b)(6) 2011, i'm not sure if the remaining mesh had anything to do with the perforation (i was diagnosed with diverticulosis).I am not sure if the bard mesh had been recalled or if anyone else may have similar issues from having a tram flap reconstruction or from a hernia repair.It was an unpleasant experience and had quite an impact on my life and from having an open wound for such a long time it had interfered with the quality of my life and being able to spend time with my children when they were younger.I had horrible pain with the mesh surfacing and at times it would poke through the wound and get caught on the gauze pads that i would have to use to protect the open wound.

• Brand Name: DOUBLE LAYER BARD MESH
• Type of Device: MESH
• Manufacturer (Section D): BARD MESH
• MDR Report Key: 6260491
• MDR Text Key: 65345386
• Report Number: MW5067291
• 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: 01/14/2017

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
• Device Operator: No Information
• Device Lot Number: 43ELD238
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALBUTEROL.; BENADRYL; CLARITIN.; FOLBIC; FRAGRANT PASSAGES (CHINESE HERBS) ; HYDROCODONE/ACETAMINOPHEN 7.5/325; HYSINGLA 40MG; OTC MEDS: MUCINEX-D EXTRA STRENGTH; POWERFUL JOINTS (CHINESE HERBS); RX MEDS: SYNTHROID 112 MC; VIMOVO 500/40; VITALITY PEARLS (CHINESE HERBS); VOLTARAN GEL
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 78