MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-04 for FURLOW INSERTER NON STERILE QB55551002 manufactured by Coloplast A/s.
[35349286]
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10
[35349287]
As reported to coloplast though not verified, furlow needle was passing on the side and furlow did not fulfill its role as a pusher. They have tried many times to achieve the goals, 1h30 intervention more than planned and more exposure of the prosthesis on the operative field, the glans trauma, to date the patient has a hematoma of the glans - hematoma is resorbing,
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2015-00126 |
| MDR Report Key | 5342129 |
| Date Received | 2016-01-04 |
| Date of Report | 2016-01-04 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2015-12-08 |
| Date Added to Maude | 2016-01-04 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINE BUCKVOLD |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024982 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FURLOW INSERTER NON STERILE |
| Generic Name | NEEDLE GUIDE |
| Product Code | KOA |
| Date Received | 2016-01-04 |
| Model Number | QB55551002 |
| Catalog Number | QB55551002 |
| Lot Number | 4199446 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, DA 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-04 |