FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 3940414
·
Received June 18, 2014
Report
- Report Number
- 2936999-2014-00507
- Event Type
- Injury
- Date Received
- June 18, 2014
- Date of Event
- May 18, 2014
- Report Date
- May 22, 2014
- Manufacturer
- COVIDIEN
- Product Code
- BTR
- PMA / PMN Number
- K090352
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4).
Description of Event or Problem · 1
A REPORT RECEIVED FROM (B)(6) STATED A PT WAS REINTUBATED BECAUSE THE 7.5 TAPERGUARD TRACHEAL TUBE CUFF WAS DEFLATED. ALTHOUGH REQUESTED, NO ADDITIONAL PT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358119 | MALLINCKRODT | TAPERGUARD ORAL/NASAL TRACHEAL TUBE | BTR | COVIDIEN | 13E0145JZX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |