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 2020-02-21 for FLIP FLO LEG BAG EXTENSION 150181 manufactured by C.r. Bard, Inc. (covington) -1018233.
[183962652]
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
[183962653]
It was reported that the catheters allegedly would not drain when hooked to the leg bags, and it resulted in numerous home health calls to client homes with complaints of clients left with bladder volumes of 1200mls and up. Apparently the valve wasn't opening allowing free flow of urine, which caused by-passing and large volume of urine in bladder. It caused discomfort and frustration for the client.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01247 |
| MDR Report Key | 9740188 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-07-18 |
| Date Added to Maude | 2020-02-21 |
| 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 | FLIP FLO LEG BAG EXTENSION |
| Generic Name | CANADA LEG BAG W/ EXTENSION |
| Product Code | KNX |
| Date Received | 2020-02-21 |
| Catalog Number | 150181 |
| Lot Number | NGDS4602 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-02-21 |