MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-09-21 for MON-A-THERM ESOPHAGEAL STETHOSCOPE, 18 FR. 503-0072 manufactured by Mmj Sa De C.v. Plant 1.
[20688683]
The product was in use for at least 2 hours. At the end of the procedure, the esophageal stethoscope was removed. As the tube was removed, the balloon disconnected from the tube as it was just above the vocal cords. The balloon was easily removed and no injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681384-1996-00006 |
| MDR Report Key | 50684 |
| Report Source | 05,06 |
| Date Received | 1996-09-21 |
| Date of Report | 1996-09-20 |
| Date of Event | 1996-08-09 |
| Date Mfgr Received | 1996-08-20 |
| Date Added to Maude | 1996-11-25 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MON-A-THERM ESOPHAGEAL STETHOSCOPE, 18 FR. |
| Generic Name | ESOPHAGEAL STETHOSCOPE |
| Product Code | BZW |
| Date Received | 1996-09-21 |
| Model Number | NA |
| Catalog Number | 503-0072 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 51386 |
| Manufacturer | MMJ SA DE C.V. PLANT 1 |
| Manufacturer Address | 716 PONCIANO ARRIAGA JUAREZ/CHIH MX |
| Baseline Brand Name | MON-A-THERM ESOPHAGEAL STETHOSCOPE 18FR |
| Baseline Generic Name | ESOPHAGEAL STETHOSCOPE W/ OR WO/TEMPERATURE SENSOR |
| Baseline Model No | NA |
| Baseline Catalog No | 503-0072 |
| Baseline ID | NA |
| Baseline Device Family | ES/EST/EST-GS/EST-XL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K811862 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-09-21 |