MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-06 for LATEX EXTENSION TUBING - NON STERILE 650615 manufactured by Productos Para El Cuidado De La Salud -9611590.
[76819107]
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 state the following: "following precautions to avoid a failure possibility of the device may cause allergy: for use with male external catheters. Caution: this product contains natural rubber latex which may cause allergic reactions. Recommended for use with all bard? Male external catheters. Directions for use: insert universal adapter connecting cone into end of male external catheter. Measure distance to urine bag, and cut tubing if necessary. Attach tubing end to inlet cone of urine bag. (detach by rolling back tubing end from inlet cone). Caution: this product contains natural rubber latex which may cause allergic reactions. For use with male external catheters. (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
[76819108]
It was reported that the extension tubing allegedly caused blistering. The patient is currently using a prescribed cream from his physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-02984 |
| MDR Report Key | 6616435 |
| Date Received | 2017-06-06 |
| Date of Report | 2017-06-06 |
| Date Mfgr Received | 2017-05-15 |
| Date Added to Maude | 2017-06-06 |
| 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 | LATEX EXTENSION TUBING - NON STERILE |
| Generic Name | EXTENSION TUBING |
| Product Code | NNW |
| Date Received | 2017-06-06 |
| Catalog Number | 650615 |
| 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 | 2017-06-06 |