InjuryJAC
A-SPOT
Received Oct 22, 2018 · Event occurred Sep 12, 2018
Report 9021987-2018-00005 · MDR key 7992331
Device
Generic name
Palpable Mass Marker
Manufacturer
Beekley CorporationModel number
651Catalog number
651
Lot number
651.06151601
Product problems
- Material Separation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER NOTIFIED BEEKLEY OF THE PRODUCT ISSUE ON (B)(6) 2018. HOWEVER, THE CUSTOMER CONFIRMED THAT A PATIENT HAD THEIR MAMMOGRAM REPEATED DUE TO THE PRODUCT ISSUE ON (B)(6) 2018.
Description of Event or Problem
THE IMAGING COMPONENT OF THE A-SPOT PALPABLE MASS MARKER SEPARATED FROM THE ADHESIVE COMPONENT AND THEREFORE DID NOT SHOW UP ON THE MAMMOGRAM IMAGE. AS A RESULT, THE MAMMOGRAM WAS REPEATED.