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 |