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

Model Number	39303
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿viscometer failure or mechanical failure ¿.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 were found adequate and state the following: "if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive".It also states "precaution: do not use if allergic reaction occurs or if patient has known allergies to device components".
Event or Problem Description
It was reported that the patient experienced skin irritation from the male external catheters.No medical intervention was reported.Per follow up on 09feb2021, the glue did not stick on the male external catheter, and the catheter would fall immediately during use even though it was the correct size.The customer noted the area was cleaned and dried prior to applying and no lotions or creams were added.The customer then switched to using item 39303 and noted the catheter had strong adhesive and so was sticking to the patient too hard which caused irritation.The customer reportedly used a warm wash cloth to assist in removing the catheter.Over-the-counter calmoseptine cream was used on the reaction.The customer switched to using the natural male external catheter and it also seemed to be causing some irritation to the patient.Patient uses otc calmoseptine cream for the irritation.The customer suggests that a pad should be made over the rough portion of the velcro strap of the male external catheter because it was not smooth on the patient¿s skin.

• Brand Name: SPIRIT HYDROCOLLOID ADHESIVE SHEATH
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11412084
• Report Number: 1018233-2021-00989
• Device Sequence Number: 11608610
• Product Code: NNX
• UDI-Device Identifier: 00801741071348
• UDI-Public: (01)00801741071348
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 39303
• Device Catalogue Number: 39303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other