MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-01-03 for SL FOLEY SWIVEL SILICONE TRICOT 25BX FOL0102 manufactured by C.r. Bard, Inc. (covington) -1018233.
[178645738]
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
[178645739]
It was reported that the clip on the foley statlock was defective. It was later reported from the ibc via email 20dec2019 that the clip part of the stat lock became disconnected from the adhesive part of the device 3 weeks of use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00080 |
| MDR Report Key | 9545178 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-31 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2018-11-23 |
| Date Added to Maude | 2020-01-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | STATLOCK FOLEY SWIVEL SILICONE TRICOT 5ST |
| Product Code | EYJ |
| Date Received | 2020-01-03 |
| Returned To Mfg | 2020-01-13 |
| Catalog Number | FOL0102 |
| Lot Number | JUCYF144 |
| 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 | 2020-01-03 |