MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-05 for RUSCH MALLONEY FR28F 9213 UNKNOWN manufactured by Teleflexmedical.
[1723920]
Pt scheduled for laparoscopic roux-en-y procedure. Difficult placement of ng tube requiring placement of bougie dilator to assist in ng insertion which was final phase of operative procedure to assure no evidence of leak. Bougie was a rusch hurst style manufactured prior to 2003. Bougie was modified to assist in the insertion of the nasogastric tube. A suture was placed through one end of the dilator with a tail of suture material attached. It was discovered that the suture had apparently punctured the inner lumen of the dilator, allowing mercury to escape outside of the dilator. Frequency: 10 minutes x1. Route: nasal. Dates of use: 10 minutes. Diagnosis or reason for use: assist in placement of nasogastric tube. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018908 |
| MDR Report Key | 1957358 |
| Date Received | 2011-01-05 |
| Date of Report | 2011-01-05 |
| Date of Event | 2011-01-04 |
| Date Added to Maude | 2011-01-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH MALLONEY FR28F |
| Generic Name | BOUGIE |
| Product Code | FAT |
| Date Received | 2011-01-05 |
| Model Number | 9213 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Device Expiration Date | 2011-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEXMEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2011-01-05 |