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 2019-11-18 for SL FOLEY SWIVEL SILICONE TRICOT 25BX FOL0102 manufactured by C.r. Bard, Inc. (covington) -1018233.
Report Number | 1018233-2019-07355 |
MDR Report Key | 9334956 |
Report Source | CONSUMER,DISTRIBUTOR,OTHER |
Date Received | 2019-11-18 |
Date of Report | 2019-11-18 |
Date Mfgr Received | 2019-10-28 |
Date Added to Maude | 2019-11-18 |
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 SILICONE TRICOT 25BX |
Generic Name | SL FOLEY |
Product Code | EYJ |
Date Received | 2019-11-18 |
Catalog Number | FOL0102 |
Lot Number | UNK |
Operator | LAY USER/PATIENT |
Device Availability | N |
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 | 2019-11-18 |