FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 6079341
·
Received November 4, 2016
Report
- Report Number
- 2936999-2016-00929
- Event Type
- Injury
- Date Received
- November 4, 2016
- Report Date
- October 6, 2016
- Manufacturer
- ATHLONE-RX
- Product Code
- ---
- PMA / PMN Number
- K142296
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PATIENT INFORMATION (ID, AGE, SEX, WEIGHT) AS WELL AS ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT HAVE BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT. THE CUSTOMER DID NOT RETAIN THE LOT NUMBER WHICH DETERMINES THE DATE OF MANUFACTURE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A CONTINUOUS CUFF LEAK. THE TUBE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729538 | MALLINCKRODT | 8.0MM SHIL CUFFED TRACH CANN | --- | ATHLONE-RX | 7CN80A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |