MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-21 for MALONEY DILATORS 40 FR = 1210 - 14 44 FR = 1210 - 44 manufactured by Medovations.
[10139]
Following esophageal dilation, patient developed severe abdominal pain, diaphoresis; sustained perforation of stomach. Underwent exploratory laparotomy and thoracotomy with repair of perforation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17308 |
| MDR Report Key | 17308 |
| Date Received | 1994-07-21 |
| Date of Report | 1994-06-29 |
| Date of Event | 1994-06-17 |
| Date Facility Aware | 1994-06-17 |
| Report Date | 1994-06-29 |
| Date Added to Maude | 1994-11-01 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALONEY DILATORS |
| Generic Name | ESOPHAGEAL DILATORS |
| Product Code | KCF |
| Date Received | 1994-07-21 |
| Model Number | 40 FR = 1210 - 14 |
| Catalog Number | 44 FR = 1210 - 44 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17240 |
| Manufacturer | MEDOVATIONS |
| Manufacturer Address | 102 E. KEEFE AVENUE MILWAUKEE WI 53212 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-21 |