MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-08 for JACKSON 5" TRACHEAL HOOK 514431 * manufactured by Msi Surgical Solutions.
[19909498]
A small piece of the tracheal hook right angle broke off while trach was being pulled on patient with respiratory failure. There was no adverse outcome to the patient. The hook and the broken piece were returned to msi surgical solutions, who is responsible for equipment on the trays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1664171 |
| MDR Report Key | 1664171 |
| Date Received | 2010-04-08 |
| Date of Report | 2010-04-08 |
| Date of Event | 2010-04-05 |
| Report Date | 2010-04-08 |
| Date Reported to FDA | 2010-04-08 |
| Date Added to Maude | 2010-04-21 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | JACKSON 5" TRACHEAL HOOK |
| Generic Name | RETRACTOR, HOOK |
| Product Code | KCH |
| Date Received | 2010-04-08 |
| Model Number | 514431 |
| Catalog Number | * |
| Lot Number | FF0 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 9 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MSI SURGICAL SOLUTIONS |
| Manufacturer Address | 225 UNDERHILL BLVD. SYOSSET NY 11791 US 11791 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-08 |