FDA Adverse Event
Other
Summary report: N
FINGER TRAP (SINGLE) MEDIUM, DISPOSABLE
MDR report key: 3095663
·
Received April 26, 2013
Report
- Report Number
- 1221538-2013-00007
- Event Type
- Other
- Date Received
- April 26, 2013
- Date of Event
- March 28, 2013
- Report Date
- April 26, 2013
- Manufacturer
- PHASE II MEDICAL MFG
- Product Code
- FWZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PARTICULATE CONTAINED IN PACKAGING IS NOT LIKELY TO CAUSE INJURY, HOWEVER PRODUCT SAMPLE ASSOCIATED WITH THE COMPLAINT HAS BEEN RETURNED TO MFR, PHASE II MEDICAL MFG FOR ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED SUBSEQUENT TO EVALUATION OF ANALYSIS RESULTS.
Description of Event or Problem · 1
ON (B)(6) 2013, (B)(4) DISTRIBUTOR (B)(6) REPORTED DISPOSABLE FINGER TRAPS WITH "DUST" OR PARTICULATE IN THE SEALED POUCHES. THE CONDITION WAS FOUND DURING INSPECTION. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181461 | FINGER TRAP (SINGLE) MEDIUM, DISPOSABLE | FINGER TRAP | FWZ | PHASE II MEDICAL MFG | R-30522-4-A1 | 406038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |