FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 2137
·
Received January 5, 1993
Report
- Report Number
- 2137
- Event Type
- Injury
- Date Received
- January 5, 1993
- Date of Event
- January 25, 1992
- Report Date
- January 25, 1992
- Manufacturer
- WELCH/ALLEN BULB
- Product Code
- FFY
- Adverse Event
- Yes
- Report Source
- User Facility report
Narratives
Description of Event or Problem · 1
THE BULB OF THE STRAIGHT BLADE LARGNPOSCOPE CAME OUT WHILE ATRTEMPTING TO INTUBATE A PATIENTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | UNKNOWN | FFY | WELCH/ALLEN BULB | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |