MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-09-19 for MON-A-THERM 12FR 90041 manufactured by Malinckrodt.
[18606440]
The cuff covering the tubes perforated. Distal-end remained in the pattent's esophegus when the tube was removed. Staff was able to recover the cuff and remove it. There was no pt harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2005-00364 |
| MDR Report Key | 668595 |
| Report Source | 07 |
| Date Received | 2005-09-19 |
| Date of Report | 2005-08-22 |
| Date of Event | 2005-07-20 |
| Date Mfgr Received | 2005-08-22 |
| Date Added to Maude | 2006-01-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | AMBER SIMINPOUR |
| Manufacturer Street | 4280 HACIENDA DR |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9254634476 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MON-A-THERM |
| Generic Name | ESOPHAGEAL STETHOSCOPE |
| Product Code | BZW |
| Date Received | 2005-09-19 |
| Model Number | 12FR |
| Catalog Number | 90041 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 657962 |
| Manufacturer | MALINCKRODT |
| Manufacturer Address | 4280 HACIENDA DR. PLEASANTON CA 94588 US |
| Baseline Brand Name | MON-A-THERM |
| Baseline Generic Name | ESOPHAGEAL STETHOSCOPE |
| Baseline Model No | 12FR |
| Baseline Catalog No | 90041 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-19 |