MAUDE Adverse Event Report: UNKNOWN SURGICAL CLIPS; CLIP, IMPLANTABLE

Patient Problems Dehydration (1807); Headache (1880); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Inflammation (1932); Vomiting (2144); Diaphoresis (2452); Ambulation Difficulties (2544)

Event Date 09/26/2016

Event Type  Injury  

Event Description

I had mastectomy in 2012 with reconstruction with implants.I had breast implant illness and had explant with diep (deep inferior epigastric perforator) flap reconstruction on (b)(6) 2016.I have two er (emergency room) visits in 2022, (b)(6) 2022 and (b)(6) 2022.Each time i woke early in the morning with sweating and a severe headache.I could not eat or drink anything without vomiting.No doctor could see me so by 3:00 p.M.I was dehydrated and went to the er.Both occurred about twelve hours after doctor visits where my belly was pressed.One was a regular doctor palpitation and the other was a lymph massage.The first er told me i had a uti.I went to a urologist, and she said i did not have a uti (urinary tract infection).The second one, the radiologist said i had an umbilical hernia mesh and several surgical clips.First of all, i have never had a hernia and the diep flap was my only abdominal surgery.Second of all, i should not have other implants or surgical clips in me, the whole point of the surgery was to take out my implants because they were making me sick.I am allergic to various metals.The operation reports do not mention any surgical clips or mesh or any complications.I have asked about 20 surgeons, and no one will remove mesh or clips.I have had inflammation for so long that i now have bone on bone on both hips and cannot walk.Surgical clips and possible mesh, doctor refused to give me the itemized list and it is not on or (operative report).Reference reports: mw5150183, mw5150184, mw5150185.

• Brand Name: SURGICAL CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18516842
• MDR Text Key: 333086837
• Report Number: MW5150182
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CALCIUM.; MAGNESIUM.; MELOXICAM 15 MG 1 X DAY.; SURGICAL MESH.; TRAMADOL 50 MG 3 X.; VITAMIN D.
• Patient Outcome(s): Required Intervention; Disability; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White