MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-02-25 for MAGIC3 GO? INTERMITTENT URINARY CATHETER 53814G manufactured by C.r. Bard, Inc. (covington) -1018233.
[184298829]
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
[184298830]
It was reported that there was a sharp piece sticking out at the tip of the catheter. The catheter reportedly scraped the patient's urethra and caused him to experience pain and bleeding. The complainant noted that the bleeding lasted 2-3 days after using the catheter and then he had blood clots. No medical intervention was reported, however, the complainant noted that he had discontinued use of the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01316 |
| MDR Report Key | 9750778 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-02-25 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-06-17 |
| Date Added to Maude | 2020-02-25 |
| 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 | MAGIC3 GO? INTERMITTENT URINARY CATHETER |
| Generic Name | MAGIC 3 GO MALE CATHETER |
| Product Code | EZD |
| Date Received | 2020-02-25 |
| Model Number | 53814G |
| Catalog Number | 53814G |
| Lot Number | JUDS0256 |
| Operator | LAY USER/PATIENT |
| 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 | 2020-02-25 |