FDA Adverse Event
Injury
Summary report: N
HYGIENIKIT
MDR report key: 4101581
·
Received August 27, 2014
Report
- Report Number
- 3009974348-2014-00015
- Event Type
- Injury
- Date Received
- August 27, 2014
- Date of Event
- August 5, 2014
- Report Date
- August 5, 2014
- Manufacturer
- AMEDA INC.
- Product Code
- HGY
- PMA / PMN Number
- K011519
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE AMEDA SALES REPRESENTATIVE MET WITH THE HOSPITAL NURSE MANAGER ON (B)(6) 2014 AND REVIEWED THE IMPORTANCE OF PROPER BREAST FLANGE FIT. THE REPRESENTATIVE GAVE THE HOSPITAL NEW PLATINUM QUICK CARDS WITH BREAST FLANGE FIT GUIDELINES.
Description of Event or Problem · 1
ON (B)(6) 2014, AN AMEDA SALES REPRESENTATIVE, WORKING WITH (B)(4), SENT AN EMAIL TO INFORM AMEDA THAT ONE WEEK PRIOR, AN INPATIENT WAS CUT WHILE USING DUAL HYGIENIKIT BREAST FLANGES WHILE PUMPING WITH THE MULTI-USER PLATINUM PUMP. PER THE SALES REPRESENTATIVE, THE PATIENT WAS NOT FITTED FOR PROPER FLANGE SIZE UNTIL AFTER THE INJURY. AT THE TIME, THE PATIENT REPORTED "RUBBING WHILE PUMPING". THE HOSPITAL DECLINED TO RELEASE PATIENT INFORMATION DUE TO HIPPA REGULATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522513 | HYGIENIKIT | PUMP, BREAST, NON-POWERED | HGY | AMEDA INC. | 4E10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |