MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-23 for MALONEY TAPERED MERCURY-FILLED ESOPHAGEAL BOUGIES UNK 50-7679, 50 7680 manufactured by Pilling Company.
[18605452]
Pt with history of recurrent hiatus hernia reflux and stricture underwent dilatation with #42 and #44 maloney dilators. Following the passage of the #44 dilator upon relooking a small perforation was detected above the stricture. The pt was treated non-surgically with iv control of acid, ng suction and antibiotic therapy. Physician concluded that the short tapered maloney dilators are a little more rigid and less flexible than the former.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 91431 |
| MDR Report Key | 91431 |
| Date Received | 1995-01-23 |
| Date of Report | 1994-12-07 |
| Date of Event | 1994-10-31 |
| Date Facility Aware | 1994-10-31 |
| Report Date | 1994-12-07 |
| Date Added to Maude | 1997-05-20 |
| 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 TAPERED MERCURY-FILLED ESOPHAGEAL BOUGIES |
| Generic Name | MERCURY-FILL BOUGIES |
| Product Code | KCD |
| Date Received | 1995-01-23 |
| Model Number | UNK |
| Catalog Number | 50-7679, 50 7680 |
| Lot Number | UNK |
| ID Number | UNK |
| Device Expiration Date | 1996-10-30 |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 90322 |
| Manufacturer | PILLING COMPANY |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-01-23 |