MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for BARD DISPOZ-A-BAG LEG BAG UNK manufactured by Productos Para El Cuidado De La Salud -9611590.
[81140809]
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: " directions for use: 1. Separate notches within circles. Pull straps through holes and around leg. 2. Position bag on leg with flutter valve at top. 3. 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. 4. To empty dispoz-a-bag, push green lever on flip-flo valve out and down. Important: be sure to reclose flip-flo valve after emptying bag. " (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
[81140810]
It was reported that urine would not drain into the drain bag, until the patient realized that the extension tube needed to be trimmed. The complainant complained that the instructions are "not good for first time users".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-03958 |
| MDR Report Key | 6742848 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-07-25 |
| Date Mfgr Received | 2017-07-10 |
| Date Added to Maude | 2017-07-25 |
| 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 | 0 |
| Brand Name | BARD DISPOZ-A-BAG LEG BAG |
| Generic Name | LEG BAG |
| Product Code | FAQ |
| Date Received | 2017-07-25 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-07-25 |