MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2016-02-25 for LEG BAG WITH FLIP-FLO VALVE 151932 manufactured by Productos Para El Cuidado De La Salud -9611590.
[39052470]
The device was not returned for evaluation. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instruction for use states the following:? Caution: this product contains natural rubber latex which may cause allergic reactions. Sterile unless package is opened or damaged.? 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
[39052471]
It was reported that the leg straps caused a rash, as a result the patient required medical intervention. The patient was given hydrocortisone cream for the rash. The patient also alleged that the leg straps caused a bruise on his leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2016-00197 |
| MDR Report Key | 5461072 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2016-02-25 |
| Date of Report | 2016-02-02 |
| Date Mfgr Received | 2016-02-02 |
| Device Manufacturer Date | 2015-10-18 |
| Date Added to Maude | 2016-02-25 |
| 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 | 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 | 3 |
| Brand Name | LEG BAG WITH FLIP-FLO VALVE |
| Generic Name | LEG BAG STRAPS |
| Product Code | FAQ |
| Date Received | 2016-02-25 |
| Catalog Number | 151932 |
| Lot Number | NGZI4500 |
| Device Expiration Date | 2018-09-30 |
| 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 | 2016-02-25 |