MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-02-08 for DYNAMIC TUBE, BLUE 5150-0-470 manufactured by Stryker Trauma Selzach.
[19149822]
It was reported that in 2006 pt niticed a small crack, approx. 1/3 of the way through her tube. The next day crack had progressed to 2/3 of the way through tube. By evening of the same day tube had completely broken. Tube was exchanged in surgery the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031020-2006-00004 |
| MDR Report Key | 673995 |
| Report Source | 07 |
| Date Received | 2006-02-08 |
| Date of Report | 2006-01-09 |
| Date of Event | 2006-01-07 |
| Date Mfgr Received | 2006-01-09 |
| Date Added to Maude | 2006-02-15 |
| 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 | ROSE MINICIELI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 1201831500 |
| Manufacturer G1 | STRYKER TRAUMA SELZACH |
| Manufacturer Street | BOHNACKERWEG 1 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAMIC TUBE, BLUE |
| Generic Name | IMPLANT |
| Product Code | KIT |
| Date Received | 2006-02-08 |
| Model Number | NA |
| Catalog Number | 5150-0-470 |
| Lot Number | H19972 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 663283 |
| Manufacturer | STRYKER TRAUMA SELZACH |
| Manufacturer Address | * SELZACH SZ 2545 |
| Baseline Brand Name | BLUE MONOTUBE TRIAX |
| Baseline Generic Name | IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | 5150-0-470 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-02-08 |