RICHARD ALLEN REGULAR TIP PEN W/ RULER AND 6-UP LABELS
Received Jun 2, 2023 · Event occurred May 2, 2023
Report 3002750084-2023-00015 · MDR key 17046431
Device
Generic name
Skin Marker
Manufacturer
Aspen Surgical Products, CaledoniaCatalog number
2650
Lot number
301431, 296436, 307330
Product problems
- Unsealed Device Packaging
- Unsealed Device Packaging
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT THREE SKIN MARKERS WERE DISCOVERED WITH SEALING ISSUES. THE ITEMS WERE NOT IN USE. NO INJURY OR DEATH WAS REPORTED. CUSTOMER REPORTED THE ISSUE FOR MULTIPLE LOT NUMBERS. LOT NUMBER AND RESPECTED COMPLAINT NUMBERS ARE AS FOLLOWS: (B)(4), LOT#: 301431; (B)(4), LOT#: 296436; (B)(4), LOT#: 307330.
Additional Manufacturer Narrative
ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT THE PRODUCT WAS FOUND WITH SEAL ISSUES. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBER WAS PROVIDED FOR REVIEW. PHOTOGRAPHIC EVIDENCE WAS PROVIDED FOR REVIEW AS WELL. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.