MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2016-07-13 for DELUXE FABRIC LEG STRAPS, REUSABLE, NON-STERILE, LATEX FREE 150507 manufactured by Productos Para El Cuidado De La Salud -9611590.
[49495248]
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: "firstly peel the pack open and feed the straps supplied through the eyelets at the top and bottom of the bag. Make sure the straps sit behind the drainage tube as shown and the elastic material of the strap is facing the leg. " (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
[49495249]
It was reported by the patient that the straps of the leg bag allegedly cut his legs down to the bone and sliced through the leg bag itself. The patient alleges that one leg is septic so he had to use the other leg, which is badly scarred and would break down within days. The patient has no feeling in his legs; therefore, he does not realize the damage that the straps are causing him.
Patient Sequence No: 1, Text Type: D, B5
[52971025]
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: "firstly peel the pack open and feed the straps supplied through the eyelets at the top and bottom of the bag. Make sure the straps sit behind the drainage tube as shown and the elastic material of the strap is facing the leg. " (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
[52971026]
It was reported by the patient that the straps of the leg bag allegedly cut his legs down to the bone and sliced through the leg bag itself. The patient alleges that one leg is septic so he had to use the other leg, which is badly scarred and would break down within days. The patient has no feeling in his legs; therefore, he does not realize the damage that the straps are causing him.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2016-00897 |
| MDR Report Key | 5793133 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2016-07-13 |
| Date of Report | 2016-08-05 |
| Date Mfgr Received | 2016-08-05 |
| Date Added to Maude | 2016-07-13 |
| 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 | DELUXE FABRIC LEG STRAPS, REUSABLE, NON-STERILE, LATEX FREE |
| Generic Name | LEG STRAPS |
| Product Code | NNW |
| Date Received | 2016-07-13 |
| Catalog Number | 150507 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| 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 | 2016-07-13 |