MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-03-19 for PERSONAL CATHETER? INTERMITTENT CATHETER 62608 manufactured by C.r. Bard, Inc. (covington) -1018233.
[186409165]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[186409166]
It was reported that the patient experienced leakage with the catheter. Per additional information received from the complainant via email on 26feb2020, fluid leaked out when the packaging was opened and "not staying together. Per additional information received from the customer contact via phone on 26feb2020, it was noted that there was no leakage with the device, however, the catheter reportedly would loose lubrication in the middle of cathing and sometimes it was not lubricated enough to insert so the patient experienced pain with insertion. No medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01914 |
| MDR Report Key | 9853187 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-03-19 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSONAL CATHETER? INTERMITTENT CATHETER |
| Generic Name | MAGIC 3 CATHETER |
| Product Code | KOD |
| Date Received | 2020-03-19 |
| Model Number | 62608 |
| Catalog Number | 62608 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |