MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2018-12-21 for DILATION PRODUCTS UNKNOWN manufactured by C.r. Bard, Inc. (covington) -1018233.
[131166750]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[131166751]
It was reported that a female patient had a percutaneous nephrostolithotomy where an x-force nephrostomy balloon dilating catheter was used on (b)(6) 2018. A ct scan on (b)(6) 2018 was being completed for other medical reasons not related. The scan revealed a foreign body which was asymptomatic to the patient and was a coincidental finding on ct scan. A ureteroscopy showed what appeared to be part of a sheath measuring 7x7mm which was not collapsible or foldable and could not be removed during the ureteroscopy. The foreign body was removed percutaneously. A double-j stent and foley catheter was left in place after the foreign body removal. The patient was admitted on (b)(6) 2018 as a 23 hour observation patient, post foreign body removal and started on cephalexin 500 mg by mouth three times a day and continued on the same antibiotic at discharge from hospital admission. The pathology report gross examination of the foreign object was as follows, "it is a 0. 9 x 0. 6 x 0. 1 cm curvilinear portion of plastic having a lime green colored outer diameter and a tan-light blue colored inner diameter. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-06135 |
| MDR Report Key | 8189743 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-20 |
| Date Mfgr Received | 2018-11-27 |
| Date Added to Maude | 2018-12-21 |
| 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 | DILATION PRODUCTS |
| Generic Name | DILATION PRODUCTS |
| Product Code | FBW |
| Date Received | 2018-12-21 |
| Returned To Mfg | 2018-12-04 |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2018-12-21 |