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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC MAMMOMARK BIOPSY SITE IDENTIFIER

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DEVICOR MEDICAL PRODUCTS, INC MAMMOMARK BIOPSY SITE IDENTIFIER Back to Search Results
Model Number MAM3002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932)
Event Date 03/29/2012
Event Type  Injury  
Manufacturer Narrative
One mammomark biopsy site identifier, product code mam3002, was placed on (b)(6) 2012 for a palpable abnormality. The procedure was completed with no known patient hypersensitivity or immune response at that time. Per the treating physician the patient returned for follow-up visits in 2015 resulting in no change since the 2012 report. On (b)(6) 2016, the patient had returned with redness around the original biopsy site. It was reported that there was a small 2. 1cm hypo echonic mass located at the original biopsy site. The patient stated that the redness had increased and returned for another exam. During that exam it was noted that the mass had increased from 2. 1cm to 3. 2cm. The patient was given antibiotics by the physician. At the time of this report, the patient has not contacted the treating facility for any additional intervention related to this event. The mammomark biopsy site identifier is composed of a bioresorbable collagen plug embedded with a non-resorbable permanent radiopaque titanium wire marker. The collagen usually is absorbed in the body within 4 - 6 weeks, leaving the titanium wire marker. A foreign material presented in the body has the potential to create a delayed immune response. In this event, the reaction occurred approximately four years after the procedure. The ifu contains a statement in the warnings and precautions section regarding potential hypersensitivity or an immune response as: "though rare, hypersensitivity or an immune response to the mammormark device may occur. The safety and efficacy of the mammomark device have not been established for patients who have known allergies to bovine products, collagen and/or collagen products. The physician should closely monitor and treat accordingly. " at this time, it cannot be concluded that our device caused or contributed to this event. However, due to the reported reaction, the potential for a subsequent procedure and/or treatment intervention, as well as medical consultation on similar events, this event has been determined to be reportable pursuant to 21 cfr 803. As such, we are submitting this medwatch report. Device discarded by customer.
 
Event Description
The patient reported that she is having an allergic reaction to the mam3002.
 
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Brand NameMAMMOMARK
Type of DeviceBIOPSY SITE IDENTIFIER
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS, INC
300 e-business way
fifth floor
cincinnati OH 45241
Manufacturer (Section G)
DEVICOR MEDICAL PRODUCTS DE MEXICO
sor juana ines de la cruz
#20152 4-b, parque industrial
tijuana, baja california 22440
MX 22440
Manufacturer Contact
shawna rose
300 e-business way
fifth floor
cincinnati, OH 45241
5138649178
MDR Report Key5966031
MDR Text Key55222244
Report Number3008492462-2016-00041
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
PMA/PMN Number
K082278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Patient
Type of Report Initial
Report Date 09/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMAM3002
Device Catalogue NumberMAM3002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/21/2016 Patient Sequence Number: 1
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