FDA Adverse Event
Other
Summary report: N
CRYSTAL MAC 4 DISPOSABLE LARYNGOSCOPE BLADES
MDR report key: 2210089
·
Received August 3, 2011
Report
- Report Number
- 9610531-2011-00002
- Event Type
- Other
- Date Received
- August 3, 2011
- Date of Event
- July 5, 2011
- Report Date
- August 3, 2011
- Manufacturer
- PENLON LTD.
- Product Code
- CCW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT INVESTIGATED, COMPLAINT CONFIRMED.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THEIR PACK OF MAC 4 CRYSTAL DISPOSABLE LARYNGOSCOPE BLADES CONTAINED SOME MAC 3 BLADES. THE ISSUE WAS IDENTIFIED DURING A PRE-USE CHECK, THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MEDICAL INTERVENTION. ON (B)(6) 2011, THE PRODUCT WAS RETURNED AND COMPLAINT CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTAL MAC 4 DISPOSABLE LARYNGOSCOPE BLADES | RIGID LARYNGOSCOPE | CCW | PENLON LTD. | NA | 854220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |