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 |