MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-03-13 for FURLOW INSERTER NON STERILE QB55551002 manufactured by Coloplast A/s.
[69821562]
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
[69821563]
According to the available information, right distal perforation during measurement with furlow. Surgeon repaired perforation and continued with insertion of cylinders.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610711-2017-00010 |
| MDR Report Key | 6400744 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-13 |
| Date of Report | 2017-03-13 |
| Date Mfgr Received | 2017-02-17 |
| Date Added to Maude | 2017-03-13 |
| 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 G1 | COLOPLAST A/S MANUFACTURING FRANCE SAS |
| Manufacturer Street | 9 AVENUE EDMOND ROSTAND |
| Manufacturer City | SARLAT-LA-CAN[?]DA, 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 | 2017-03-13 |
| Model Number | QB55551002 |
| Catalog Number | QB55551002 |
| 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, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-13 |