MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1998-12-29 for COOK ESOPHAGEAL DILATOR SET C-CEDS-58-60 manufactured by Cook Inc..
[15448451]
The pt had a normal esophagus. The esophageal dilator was placed and placement was satisfactory. The following morning, the pt had an extremely sore throat which continued all day. Pt was placed an antibiotics that night. Tests were performed and a perforation in the neck was noted at the c4-c5 level. The pt was taken to surgery on novemebr 26, 1998. A left neck exploration and drainage was completed at that time. Pt is doing ok from this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-1998-00134 |
| MDR Report Key | 203790 |
| Report Source | 05,07 |
| Date Received | 1998-12-29 |
| Date of Report | 1998-11-30 |
| Date of Event | 1998-11-24 |
| Date Facility Aware | 1998-11-24 |
| Report Date | 1998-11-30 |
| Date Mfgr Received | 1998-11-30 |
| Date Added to Maude | 1998-12-30 |
| 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 | COOK ESOPHAGEAL DILATOR SET |
| Generic Name | DILATOR SET |
| Product Code | KCF |
| Date Received | 1998-12-29 |
| Model Number | NA |
| Catalog Number | C-CEDS-58-60 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 197940 |
| Manufacturer | COOK INC. |
| Manufacturer Address | 925 S. CURRY PIKE BLOOMINGTON IN 47403 US |
| Baseline Brand Name | COOK ESOPHAGEAL DILATOR SET |
| Baseline Generic Name | NA |
| Baseline Model No | NA |
| Baseline Catalog No | C-CEDS-58-60 |
| Baseline ID | NA |
| Baseline Device Family | DILATOR |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-12-29 |