FDA Adverse Event
Malfunction
Summary report: N
MURANAKA SURGICAL MARKING PEN W/ RULER AND LABELS, STERILE
MDR report key: 7120552
·
Received December 15, 2017
Report
- Report Number
- 1836161-2017-00130
- Event Type
- Malfunction
- Date Received
- December 15, 2017
- Date of Event
- September 12, 2017
- Report Date
- January 4, 2018
- Manufacturer
- ASPEN SURGICAL PRODUCTS, CALEDONIA
- Product Code
- FZZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PENDING DEVICE RETURN.
Description of Event or Problem · 1
ITEM NUMBER MMI02730PBX (SURGICAL MARKING PEN) WAS DISCOVERED WITH A DEFECTIVE SEAL.
Description of Event or Problem · 1
ITEM NUMBER MMI02730PBX (SURGICAL MARKING PEN) WAS DISCOVERED WITH A DEFECTIVE SEAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 903115 | MURANAKA SURGICAL MARKING PEN W/ RULER AND LABELS, STERILE | MARKING PEN | FZZ | ASPEN SURGICAL PRODUCTS, CALEDONIA | MMI02730PBX | 130317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |