MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-21 for E-Z-GLIDER STRAIGHT TIP .035" GW 5/BX 35BX manufactured by Acmi Corp..
[17907047]
Tip of guide wire came off when the feeding tip was taken off, no patient injury.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2124979-2002-00083 |
MDR Report Key | 429860 |
Date Received | 2002-11-21 |
Date of Report | 2002-11-19 |
Date of Event | 2002-07-10 |
Date Added to Maude | 2002-12-02 |
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 |
Manufacturer Contact | DON KEREN |
Manufacturer Street | 136 TURNPIKE RD |
Manufacturer City | SOUTHBOROUGH MA 01772 |
Manufacturer Country | US |
Manufacturer Postal | 01772 |
Manufacturer Phone | 5088042708 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | E-Z-GLIDER STRAIGHT TIP .035" GW 5/BX |
Generic Name | * |
Product Code | EYA |
Date Received | 2002-11-21 |
Returned To Mfg | 2002-09-24 |
Model Number | 35BX |
Catalog Number | 35BX |
Lot Number | 916072C |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | U |
Device Sequence No | 1 |
Device Event Key | 418851 |
Manufacturer | ACMI CORP. |
Manufacturer Address | 3037 MT. PLEASANT STREET RACINE WI 53404 US |
Baseline Brand Name | E-Z GLIDER GUIDEWIRE |
Baseline Generic Name | URETERAL GUIDEWIRE |
Baseline Catalog No | 35BX |
Baseline ID | .035", 150CM, S |
Baseline Device Family | HYDROPHILIC COATED GUIDEWIRE |
Baseline Shelf Life Contained | Y |
Baseline Shelf Life [Months] | 60 |
Baseline PMA Flag | N |
Baseline 510K PMN | N |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | Y |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2002-11-21 |