MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SPIRIT HYDROCOLLOID ADHESIVE SHEATH; MALE EXTERNAL CATHETER

Model Number 35302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

¿the investigation is still in progress.Once the investigation is complete a supplemental report will be filed.¿ the device was not returned.

Event Description

It was reported that the patient experienced pain while removing the externals.No medical intervention reported.

Manufacturer Narrative

Per clinical review, it has been determined that this event is not reportable.The device was not returned.H11:section a through f - the information provided by bd 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 bd.The device was not returned.

Event Description

It was reported that the patient experienced pain while removing the externals.No medical intervention reported.

• Brand Name: SPIRIT HYDROCOLLOID ADHESIVE SHEATH
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10089416
• MDR Text Key: 193637990
• Report Number: 1018233-2020-03369
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070938
• UDI-Public: (01)00801741070938
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 35302
• Device Catalogue Number: 35302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1