MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-09-04 for RIGID CURVE POSITIONER RCP manufactured by Power Medical Interventions.
[15007279]
Difficulty inserting 29mm dlu into rectum; three dlus detached from "flexshft" at the rectal stump. Required much work to access and retrieve detached dlus transanally.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2532140-2002-00007 |
MDR Report Key | 417914 |
Report Source | 05 |
Date Received | 2002-09-04 |
Date of Report | 2002-09-04 |
Date of Event | 2002-02-12 |
Date Mfgr Received | 2002-02-12 |
Date Added to Maude | 2002-09-24 |
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 | 0 |
Manufacturer Contact | LARRY POTTER |
Manufacturer Street | 110 UNION SQUARE DRIVE |
Manufacturer City | NEW HOPE PA 18938 |
Manufacturer Country | US |
Manufacturer Postal | 18938 |
Manufacturer Phone | 2677758100 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RIGID CURVE POSITIONER |
Generic Name | PROBE DIRECTOR |
Product Code | EXX |
Date Received | 2002-09-04 |
Returned To Mfg | 2002-02-21 |
Model Number | NA |
Catalog Number | RCP |
Lot Number | NA |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 406949 |
Manufacturer | POWER MEDICAL INTERVENTIONS |
Manufacturer Address | 110 UNION SQUARE DRIVE NEW HOPE PA 18938 US |
Baseline Brand Name | RIGID CURVE POSITIONER |
Baseline Generic Name | PROBE DIRECTOR |
Baseline Model No | NA |
Baseline Catalog No | RCP |
Baseline ID | * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other; 2. Required No Informationntervention | 2002-09-04 |