MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2017-03-31 for BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC STRAPS, 150732 manufactured by Productos Para El Cuidado De La Salud -9611590.
[71391433]
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
[71391434]
It was reported that the drain bag was leaking from the seams around the drain valve. The patient allegedly experienced a uti that was treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[74722849]
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 states the following: "3. Malfunction and adverse events: - catheter kinking, damage, rupture. - difficulty or failure to remove the device. - occlusion of catheter inner lumens. - encrustation. - accidental removal of the device due to leakage of sterile water or balloon rupture. - device damage due to inappropriate use. - failure to measure temperatures. - improper temperature indication. 2) adverse events: - urinary-tract infection. - hemorrhage, hematuria. - allergy reaction to the device. - calculus formation. - edema. - pain. - discomfort. - injury of bladder or urethral. - urethritis, urinary incontinence. - retained balloon fragments. " (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
[74722850]
It was reported that the drain bag was leaking from the seams around the drain valve. The patient allegedly experienced a uti that was treated with antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-01466 |
| MDR Report Key | 6449082 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2017-03-31 |
| Date of Report | 2017-05-03 |
| Date Mfgr Received | 2017-04-13 |
| Date Added to Maude | 2017-03-31 |
| 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 WITH FLIP-FLO DRAINAGE VALVE, FABRIC STRAPS, |
| Generic Name | DRAIN BAG |
| Product Code | FAQ |
| Date Received | 2017-03-31 |
| Catalog Number | 150732 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Required No Informationntervention | 2017-03-31 |