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 2020-03-31 for SILIC FOLEY CATH AA61161002 AA6116 manufactured by Coloplast A/s.
[186357500]
After receiving this complaint, we searched for other complaint and we didn't find other complaint on the lot number 7210767. Checking the quality databases revealed no anomaly in connection with the described defect. However, no sample is available from the customer and we cannot go further than the documentary investigation which didn't reveal any anomaly recorded during production.
Patient Sequence No: 1, Text Type: N, H10
[186357501]
According to the available information, the catheter tore at the end and therefore a large part of it remained in the bladder/urethra. It was noted that in the presence of the health care professional the patient was not removing the catheter adequately and may have been confused. The patient was not treated as an emergent situation per report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610711-2020-00010 |
| MDR Report Key | 9903154 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH O'GARA |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | COLOPLAST A/S MANUFACTURING |
| 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 | SILIC FOLEY CATH |
| Generic Name | FOLEY CATHETER |
| Product Code | EZL |
| Date Received | 2020-03-31 |
| Model Number | AA61161002 |
| Catalog Number | AA6116 |
| Lot Number | 7210767 |
| Operator | LAY USER/PATIENT |
| 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 | 2020-03-31 |