MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-10 for MAGIC3? INTERMITTENT CATHETER WITH SURE-GRIP? SLEEVE 53616G manufactured by Davol Surgical Innovations -9616067.
[79759369]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[79759370]
It was reported that the catheter was cut in half.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-03604 |
| MDR Report Key | 6699930 |
| Date Received | 2017-07-10 |
| Date of Report | 2017-12-13 |
| Date Mfgr Received | 2017-12-12 |
| Device Manufacturer Date | 2016-12-12 |
| Date Added to Maude | 2017-07-10 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| 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 PARQUE INDUSTRIAL AEROPUERTO |
| 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? INTERMITTENT CATHETER WITH SURE-GRIP? SLEEVE |
| Generic Name | MAGIC 3 |
| Product Code | KOA |
| Date Received | 2017-07-10 |
| Model Number | 53616G |
| Catalog Number | 53616G |
| Lot Number | JUAX0746 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL SURGICAL INNOVATIONS -9616067 |
| Manufacturer Address | AVE. ROBERTO FIERRO #6408 PARQUE INDUSTRIAL AEROPUERTO CD. JUAREZ, CHIH S.A. DE C.V. 32690 MX 32690 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-10 |