FDA Adverse Event
Malfunction
Summary report: N
KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA
MDR report key: 2151364
·
Received June 8, 2011
Report
- Report Number
- 1316463-2011-00012
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Date of Event
- May 9, 2011
- Report Date
- June 3, 2011
- Manufacturer
- WELCH ALLYN
- Product Code
- HIB
- PMA / PMN Number
- K941272
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICES HAVE NOT BEEN RETURNED TO WELCH ALLYN FOR EVALUATION. RESULTS: VAGINAL SPECULUM.
Description of Event or Problem · 1
SPECULUM USED FOR PAP SMEAR SPONTANEOUSLY BROKE (ONE ARM CRACKED WITH SHARP POINT) CAUSING SMALL LACERATION TO PT WITH SMALL AMOUNT OF BLEEDING. SPECULUM HAD NOT BEEN DROPPED OR OTHERWISE INJURED, DID NOT APPEAR ABNORMAL BEFORE INSERTION. THE CUSTOMER DID NOT PROVIDE A PT IDENTIFIER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA | HIB | WELCH ALLYN | 59000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |