MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-12-09 for EMERGENGY CRICOTHYROTOMY CATHETER SET C-TCCS-600 manufactured by Cook Inc..
[16264685]
The device was placed for airway access. After placement of the catheter, the patient developed subcutaneous emphysema. The catheter was removed and it appeared to have a slit in it. It is unknown how the slit was incurred.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1820334-1998-00123 |
MDR Report Key | 200800 |
Report Source | 05 |
Date Received | 1998-12-09 |
Date of Report | 1998-11-12 |
Date of Event | 1998-11-09 |
Date Facility Aware | 1998-11-09 |
Report Date | 1998-11-12 |
Date Mfgr Received | 1998-11-12 |
Date Added to Maude | 1998-12-10 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | EMERGENGY CRICOTHYROTOMY CATHETER SET |
Generic Name | CRICOTHYROTOMY CATHETER |
Product Code | BWC |
Date Received | 1998-12-09 |
Model Number | NA |
Catalog Number | C-TCCS-600 |
Lot Number | UNK |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | UNKNOWN |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 195050 |
Manufacturer | COOK INC. |
Manufacturer Address | 925 S. CURRY PIKE BLOOMINGTON IN 47403 US |
Baseline Brand Name | EMERGENCY CRICOTHYROTOMY CATHETER SET |
Baseline Generic Name | NA |
Baseline Model No | NA |
Baseline Catalog No | C-TCCS-600 |
Baseline ID | NA |
Baseline Device Family | SPECIAL SET |
Baseline Shelf Life Contained | Y |
Baseline Shelf Life [Months] | 36 |
Baseline PMA Flag | N |
Baseline 510K PMN | N |
Baseline Preamendment | Y |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 1998-12-09 |