MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2017-02-17 for BARD DISPOZ-A-BAG LEG BAG WITH FLIP-FLO DRAINAGE VALVE, FABRIC LEG STRAPS, 18IN 150832 manufactured by Productos Para El Cuidado De La Salud -9611590.
[67701625]
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
[67701626]
It was reported that the patient developed (what the complainant described as) a "burn" on his leg, where the device rested. The patient was allegedly treated by a physician.
Patient Sequence No: 1, Text Type: D, B5
[71256678]
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.
Patient Sequence No: 1, Text Type: N, H10
[71256681]
It was reported that the patient developed (what the complainant described as) a "burn" on his leg, where the device rested. The patient was allegedly treated by a physician.
Patient Sequence No: 1, Text Type: D, B5
[73577854]
Received 1 unopened dispoz-a-bag. The reported issue was unconfirmed, as the problem could not be reproduced. During the visual inspection was found that the product was expired on 04/30/2016. All components were reviewed and not found any imperfection (foreign matter, tears, spots, contamination). The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state 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. 5. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable, local, state and federal laws and regulations" (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.
Patient Sequence No: 1, Text Type: N, H10
[73577855]
It was reported that the patient allegedly developed (what the complainant described as) a "burn" on his leg, where the device rested. Subsequently, the patient was treated by a physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-00526 |
| MDR Report Key | 6339604 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2017-02-17 |
| Date of Report | 2017-04-18 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2013-04-27 |
| Date Added to Maude | 2017-02-17 |
| 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 | 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 LEG STRAPS, 18IN |
| Generic Name | LEG BAG |
| Product Code | FAQ |
| Date Received | 2017-02-17 |
| Returned To Mfg | 2017-02-22 |
| Catalog Number | 150832 |
| Lot Number | NGXD0394 |
| Device Expiration Date | 2016-04-30 |
| 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 | 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 | 2017-02-17 |