MAUDE Adverse Event Report: SENSORY INC BARD ULTER (BREAST) TISSUE MARKER SIZE 3.5 CM L; BARD BIOPSY SYSTEM

Catalog Number GMUTC005T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Burning Sensation (2146); Numbness (2415)

Event Date 07/28/2014

Event Type  Injury  

Event Description

(b)(6), did a biopsy and shot breast core marker (bard) in rt breast and lymph node, put a breast core in my lymph node and breast without asking or explaining it at all.Bad medical personnel and lied about it.It has caused me to get hot, lump under arm, bad pain in shoulder.Under arm breast.Burning feeling in arm pit, numbness in rt wrist, pain shoot across rt.Breast, lumps on breast that come and go, infected under armpit.I've never been sick my whole life until (b)(4) doctors shot breast core marker without asking or telling me.I am having problems bad.I am angry.

• Brand Name: BARD ULTER (BREAST) TISSUE MARKER SIZE 3.5 CM L
• Type of Device: BARD BIOPSY SYSTEM
• Manufacturer (Section D): SENSORY INC; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 4825025
• MDR Text Key: 5837576
• Report Number: MW5042943
• Device Sequence Number: 1
• Product Code: NEU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Catalogue Number: GMUTC005T
• Device Lot Number: VTI3M1479
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 73