MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-23 for SAVERY DILATOR 38 FR. 12.8MM UNKNOWN manufactured by Wilson - Cook.
[4703]
Savery dilator used during a gastroscopy procedure. Dilitation was performed and the patient tolerated the procedure well. A follow up barium swallow was done which showed a small esophageal leak. The patient was transferred to another facility for surgical consult. This a possible complication of this type of procedure. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8175 |
| MDR Report Key | 8175 |
| Date Received | 1993-07-23 |
| Date of Event | 1993-03-18 |
| Date Facility Aware | 1993-03-29 |
| Date Reported to Mfgr | 1993-04-06 |
| Date Added to Maude | 1994-07-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAVERY DILATOR 38 FR. 12.8MM |
| Generic Name | SAVERY |
| Product Code | EZM |
| Date Received | 1993-07-23 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 7850 |
| Manufacturer | WILSON - COOK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-07-23 |