FDA Adverse Event
Injury
Summary report: N
APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT
MDR report key: 4211640
·
Received October 29, 2014
Report
- Report Number
- 2024800-2014-00004
- Event Type
- Injury
- Date Received
- October 29, 2014
- Date of Event
- September 25, 2014
- Report Date
- October 24, 2014
- Manufacturer
- HOLOGIC, INC.
- Product Code
- LSL
- PMA / PMN Number
- K003395
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
GP HAVING TAKEN NORMAL VAGINAL SWAB WAS TRANSFERRING TO THE TRANSPORT TUBE AND "BREAKING" THE HEAD WITHIN THE TUBE RATHER THAN BREAKING IN ITS DESIGNED SPOT, THE PINK HANDLE BROKE IN TWO PLACES WITH A ONE CM PART FLYING BACK UP WITH SOME FORCE INTO THE GP'S EYE CAUSING DISTRESS TO HER. MAIN PART OF THE SWAB SAMPLE REMAINED IN BOTTLE, MAIN PART OF STEM IN HAND. THE USER TOOK STEPS TO IRRIGATE EYE IN CASE OF LOCAL CONTAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692490 | APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT | IN-VITRO DIAGNOSTIC ASSAY | LSL | HOLOGIC, INC. | 301162 | 108908A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |