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 2020-01-31 for SL FOLEY SWIVEL 25BX FOL0101 manufactured by C.r. Bard, Inc. (covington) -1018233.
[183167362]
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
[183167363]
It was reported that the stalocks will not remain closed when attached to the foley.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1018233-2020-00681 |
MDR Report Key | 9653280 |
Report Source | CONSUMER,DISTRIBUTOR,OTHER |
Date Received | 2020-01-31 |
Date of Report | 2020-02-24 |
Date Mfgr Received | 2020-02-23 |
Device Manufacturer Date | 2019-07-19 |
Date Added to Maude | 2020-01-31 |
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 | SL FOLEY SWIVEL 25BX |
Generic Name | STATLOCK |
Product Code | EYJ |
Date Received | 2020-01-31 |
Catalog Number | FOL0101 |
Lot Number | JUDUF219 |
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 | 2020-01-31 |