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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON, ETHICON DIVISION TITANIUM BREAST CLIP

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JOHNSON AND JOHNSON, ETHICON DIVISION TITANIUM BREAST CLIP Back to Search Results
Event Date 04/30/2010
Event Type  Injury  
Event Description

On (b)(6), 2010, a breast biopsy was performed and a titanium clip manufactured by johnson and johnson was placed into the site. A mammogram was performed after the procedure to verify the location of the clip. One the third day, after the procedure, pt was noticeably out of breathe after walking up 10 stairs. On the 4th day, she had a sore neck. On the 5th day, the sore neck was much worse and it was difficult for her to turn her head from side to side, also, she has a different pain in her breast, that does not seem at all related to the biopsy. On the 6th day, the pain was worse in her neck and the pain also extended down her right arm, into her right shoulder and right shoulder blade, and then into the right ear and right jaw. She also feels ill, she is having difficulty sleeping. She is also experiencing tingling and then numbness in her right hand. The pain in her breast is becoming more constant, the pain is a deep ache and the breast feels heavy. She went to see her primary health care provider who believes that she is having a reaction to the titanium clip. Her primary health care provider referred her to a breast specialist for eval. The pain in her breast continued to get worse. The pain would always be present, but it would sometimes be a sharp stabbing pain and sometimes a stinging pain. She also had itching and burning in the breast. The breast specialist agreed that the problem could be the clip but after performing a sonogram noted that there was a hematoma present in the breast. The recommendation at that point was to wait a few weeks until the hematoma was resolved before going back into the breast before it was healed. The pain continued to be present and 4 weeks after the biopsy, the pain in the breast is worse than before. The breast specialist performs a second ultrasound on (b)(6), 2010, and notes that the hematoma is very small and therefore, concludes that the clip is the cause of the pain. The clip is removed from the breast on (b)(6), 2010. The pt has complete relief from the breast pain 4 days after removal of the clip. The pt's other symptoms are also slowly resolving. Dates of use: (b)(6) 2010 - (b)(6) 2010. Diagnosis or reason for use: mark site of breast biopsy. Event abated after use stopped or dose reduced: yes.

 
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Brand NameTITANIUM BREAST CLIP
Type of DeviceTITANIUM BREAST CLIP
Manufacturer (Section D)
JOHNSON AND JOHNSON, ETHICON DIVISION
MDR Report Key1758069
Report NumberMW5016702
Device Sequence Number1
Product CodeNEU
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 07/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 07/09/2010 Patient Sequence Number: 1
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