MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for MAGIC3? HYDROPHILIC INTERMITTENT CATHETER, FEMALE 51614S manufactured by C.r. Bard, Inc. (covington) -1018233.
[135157643]
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
[135157644]
It was reported that the magic 3 catheter failed the visual analysis evaluation. Fda customs detained this product at the border where it was randomly selected to be sampled and sent to an fda selected laboratory for inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-00588 |
| MDR Report Key | 8304703 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-03-26 |
| Date Mfgr Received | 2019-03-06 |
| Date Added to Maude | 2019-02-05 |
| 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 | 0 |
| Brand Name | MAGIC3? HYDROPHILIC INTERMITTENT CATHETER, FEMALE |
| Generic Name | MAGIC 3 CATHETER |
| Product Code | OHR |
| Date Received | 2019-02-05 |
| Model Number | 51614S |
| Catalog Number | 51614S |
| 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 | 2019-02-05 |