MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-15 for BARD DISPOZ-A-BAG LEG BAG UNKNOWN manufactured by Productos Para El Cuidado De La Salud -9611590.
[50446906]
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: "- position bag on leg with flutter valve at top. - attach catheter or extension tubing to top inlet. When wearing bag below knee, attach bard? Extension tubing (catalog no. 150615 or 4a4194). When using extension tubing, make sure to connect tube at least to the 3rd taper of the connector. -to empty dispoz-a-bag? , push green lever on flip-flo? Valve out and down. " (b)(4). The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[50446907]
It was reported that the drain bag creates a vapor lock after it is washed, cleaned and air drys for 12 hours. The patient allegedly pulls the bag apart before re-use of the product. The drain bag allegedly creates a vapor lock again while in use, and as a result, the urine backs up. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2016-00902 |
| MDR Report Key | 5798118 |
| Date Received | 2016-07-15 |
| Date of Report | 2016-06-20 |
| Date Mfgr Received | 2016-06-20 |
| Date Added to Maude | 2016-07-15 |
| 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 FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JANNA PARKS |
| 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 | 0 |
| Brand Name | BARD DISPOZ-A-BAG LEG BAG |
| Generic Name | LEG BAG |
| Product Code | FAQ |
| Date Received | 2016-07-15 |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2016-07-15 |