MalfunctionLRY
UNI-PUNCH
Received Feb 5, 2020 · Event occurred Jan 13, 2020
Report 0002521453-2020-00001 · MDR key 9673222
Device
Generic name
Biopsy Punch
Manufacturer
Premier Dental Products Co. Dba Premier MedicalCatalog number
9033508
Lot number
P17030680
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Not reported
- Infiltration into Tissue
- Infiltration into Tissue
Narrative
Additional Manufacturer Narrative
BIOPSY PUNCH LEFT A DARK RESIDUE ON PATIENT'S SKIN POST PROCEDURE. BIOPSY PUNCHES ARE DELIVERED STERILE AND NO HARM TO PATIENT REPORTED.
Description of Event or Problem
BIOPSY PUNCH LEFT A DARK RESIDUE ON PATIENT'S SKIN POST PROCEDURE. BIOPSY PUNCHES ARE DELIVERED STERILE AND NO HARM TO PATIENT REPORTED.
Remedial action
- Other