MAUDE Adverse Event Report: TITANIUM CLIP; CLIP, IMPLANTABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 03/01/2020

Event Type  Injury  

Event Description

I have had an ongoing ache in my left breast, pain in my arm and occasionally i have shooting pains in the exact location where a titanium clip was placed after a breast biopsy.Fda safety report id# (b)(4).

• Brand Name: TITANIUM CLIP
• Type of Device: CLIP, IMPLANTABLE
• MDR Report Key: 9962261
• MDR Text Key: 187858820
• Report Number: MW5094147
• 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: 04/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 47