MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-02-27 for SL FOLEY SWIVEL SILICONE TRICOT 25BX FOL0102CE manufactured by C.r. Bard, Inc. (covington) -1018233.
[184649246]
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
[184649247]
It was reported that the retainer broke off the statlock on the 6th day after placement.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1018233-2020-01406 |
MDR Report Key | 9765798 |
Report Source | DISTRIBUTOR,OTHER |
Date Received | 2020-02-27 |
Date of Report | 2020-03-18 |
Date of Event | 2020-01-20 |
Date Mfgr Received | 2020-03-13 |
Device Manufacturer Date | 2019-02-15 |
Date Added to Maude | 2020-02-27 |
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 | FOLEY STABLISATION DEVICE |
Product Code | EYJ |
Date Received | 2020-02-27 |
Returned To Mfg | 2020-02-21 |
Catalog Number | FOL0102CE |
Lot Number | JUDNF605 |
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 | 2020-02-27 |