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 2019-02-01 for LEG BAG WITH FLIP-FLO? VALVE 151932 manufactured by C.r. Bard, Inc. (covington) -1018233.
[134773232]
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
[134773233]
It was reported that the tubing connected to the patients suprapubic catheter was causing blisters on the patients abdomen. Reportedly, the tubing did not stay connected to the leg bag and easily separated. No medical intervention was reported. Per additional information received from patient's wife via the phone on (b)(6) 2018, she advised that she was taking the patient back to a dermatologist to determine if he had an infection or a skin sensitivity to the tubing material. Per additional information received from patient's wife via the phone on (b)(6) 2019, she stated that the dermatologist performed a biopsy on (b)(6) 2019 and the results will be available in a couple of weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-00550 |
| MDR Report Key | 8297476 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2019-02-01 |
| Date of Report | 2019-04-19 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-02-01 |
| 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 | LEG BAG WITH FLIP-FLO? VALVE |
| Generic Name | LEG BAG |
| Product Code | FAQ |
| Date Received | 2019-02-01 |
| Returned To Mfg | 2019-03-11 |
| Catalog Number | 151932 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| 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 | 1. Required No Informationntervention | 2019-02-01 |