MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-03 for BARD DISPOZ-A-BAG LEG BAG UNK manufactured by Productos Para El Cuidado De La Salud -9611590.
[74421205]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[74421206]
It was reported that urine would not drain into the leg bag. The complainant stated that he noticed the issue right away and replaced the bag with a new drain bag.
Patient Sequence No: 1, Text Type: D, B5
[77956263]
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use. If package is opened or if any imperfection or surface deterioration is observed, do not use. Periodic observations of this system should be made to ensure that urine is flowing freely. If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction. If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed. Kink drainage tubing a minimum of 3 inches below the sampling port until urine is visible under the access site. " (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[77956264]
It was reported that urine would not drain into the leg bag. The complainant stated that he noticed the issue right away and replaced the bag with a new drain bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-02255 |
| MDR Report Key | 6540260 |
| Date Received | 2017-05-03 |
| Date of Report | 2017-05-26 |
| Date Mfgr Received | 2017-05-04 |
| Date Added to Maude | 2017-05-03 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Street | KM. 7 CARRETERA INTERNACIONAL |
| Manufacturer City | NOGALES, SONORA 85621 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 85621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD DISPOZ-A-BAG LEG BAG |
| Generic Name | LEG BAG |
| Product Code | FAQ |
| Date Received | 2017-05-03 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Address | KM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA 85621 MX 85621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-03 |