MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 LATEX EXTENSION TUBING - NON STERILE

Catalog Number	650615
Health Effect - Clinical Codes	Skin Irritation (2076); Alteration In Body Temperature (2682)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the extension tubing allegedly caused blistering.The patient is currently using a prescribed cream from his physician.

• Brand Name: LATEX EXTENSION TUBING - NON STERILE
• Common Device Name: EXTENSION TUBING
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6616435
• Report Number: 1018233-2017-02984
• Device Sequence Number: 789127
• Product Code: NNW
• UDI-Device Identifier: 00801741050978
• UDI-Public: (01)00801741050978
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 650615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1