MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-23 for FREEDOM SELF-CATH NELATON CH1 5045201400 manufactured by Coloplast A/s.
[26784146]
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurence. Should additional facts prompt us to alter or supplement any information or 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
[26784147]
According to the information received, end user has been cathing since he was (b)(6) and when he puts the lubrication on the cath and inserts nothing comes out. He then removes the catheter and then realizes there are no eyelets. Eu has about 50 caths that don't have eyelets that he has used. End user gets them from j&b and will get his next shipment the first of the month of 260 and caths 6-10 times a day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005945907-2015-00003 |
| MDR Report Key | 5099013 |
| Date Received | 2015-09-23 |
| Date of Report | 2015-09-23 |
| Date of Event | 2015-08-24 |
| Date Mfgr Received | 2015-08-24 |
| Date Added to Maude | 2015-09-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRIAN SCHMIDT |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024987 |
| Manufacturer G1 | COLOPLAST A/S ZHUHAI |
| Manufacturer Street | BAO GHENG RD |
| Manufacturer City | ZHUHAI, GUANGDONG 519090 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 519090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FREEDOM SELF-CATH NELATON CH1 |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 2015-09-23 |
| Model Number | 5045201400 |
| Catalog Number | 5045201400 |
| Device Availability | Y |
| 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. Required No Informationntervention | 2015-09-23 |