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

Patient Problems Fatigue (1849); Rash (2033); Arthralgia (2355); Unspecified Gastrointestinal Problem (4491); Swelling/ Edema (4577)

Event Date 07/01/2006

Event Type  Injury  

Event Description

Surgical clips went in and not long after my stomach started swelling shut whenever i was exposed to allergens.It basically induced oral allergy syndrome.Had chronic sinus issues, fatigue and joint pain which got worse over time.I developed rashes that would not go away.Once the clips were removed after a few weeks i started to get my energy back again.I felt like my old self, it was easier to work a full day and have some energy left at the end of it.Bad experiences seemed easier to deal with.I felt like going to the gym as opposed to just barely having enough energy that i could force myself to go.My sinuses are better as well, they are not as persistent at least.Mental clarity is better too.It would have been nice to know they were in me at the time they went in for gall bladder removal.If you need pictures of product let me know.I don't have them available today.

• Brand Name: SURGICAL CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18898561
• MDR Text Key: 337785535
• Report Number: MW5152809
• 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: 03/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: "NSIDS".; "VARIOUS HERBAL TREATMENTS".; ANT-HISTAMINES.; GOLD CROWN.; MESH (WAS REMOVED).; MULTI-VITAMINS.; PREDNISONE.; TYLENOL.
• Patient Outcome(s): Disability
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White