MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-22 for FURLOW INSERTER NON STERILE QB55551002 manufactured by Coloplast A/s.
[103161215]
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[103161216]
According to the available information, when using the keith needle on the dacron pull suture - when you deploy it through the glans the dacron suture is frayed and fall to bits. This means you cannot locate the implant in the shaft. There appears to be no clinical consequences. The operation time was excessive, but coloplast has not been alerted to any infection or impaired function.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610711-2018-00006 |
| MDR Report Key | 7361404 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-22 |
| Date of Report | 2018-07-10 |
| Date Mfgr Received | 2018-03-01 |
| Date Added to Maude | 2018-03-22 |
| 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 | STEPHANIE PERRYMAN |
| Manufacturer Street | 1601 WEST RIVIER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6124345685 |
| Manufacturer G1 | COLOPLAST A/S MANUFACTURING FRANCE |
| Manufacturer Street | 9 AVENUE EDMOND ROSTAND |
| Manufacturer City | SARLAT-LA-CANEDA, 24206 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 24206 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FURLOW INSERTER NON STERILE |
| Generic Name | NEEDLE GUIDE |
| Product Code | KOA |
| Date Received | 2018-03-22 |
| Returned To Mfg | 2018-03-06 |
| Model Number | QB55551002 |
| Catalog Number | QB55551002 |
| Lot Number | 6009375 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-22 |