MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC POP-ON M 30BX

Model Number	32302
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091); Reaction (2414)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient experienced an allergic skin reaction on his penis.Per additional information from (b)(4) via email (b)(6) 2019; after use of the mec sheaths, the patient noticed a burning sensation on the penile skin, causing swelling and redness.This later turned into red and spotty bubbles.The patient visited the urologist and was tested for a fungal infection, which was negative.The doctor prescribed an anti-fungal ointment and recommended chamomile baths to clear the rash reaction.The patient has since discontinued use of the mec sheaths.The patient used the sheaths for 7 months before prior to this event.Per additional information from (b)(4) via email (b)(6) 2019; as of (b)(6) 2019 the patients skin has healed and the patient has resumed using the mec sheaths with no issues.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "description/indication the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication do not use on irritated or compromised skin.Precaution do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) open package at perforation.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release.5) unroll self-adhering catheter over penis.6) gently squeeze the catheter to properly seal adhesive to the skin.7) connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.Directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.".
Event or Problem Description
It was reported that the patient experienced an allergic skin reaction on his penis.Per additional information from the ibc via email (b)(6)2019 ; after use of the mec sheaths, the patient noticed a burning sensation on the penile skin, causing swelling and redness.This later turned into red and spotty bubbles.The patient visited the urologist and was tested for a fungal infection, which was negative.The doctor prescribed an anti-fungal ointment and recommended chamomile baths to clear the rash reaction.The patient has since discontinued use of the mec sheaths.The patient used the sheaths for 7 months before prior to this event.Per additional information from the ibc via email(b)(6)2019 ; as of(b)(6)2019 the patients skin has healed and the patient has resumed using the mec sheaths with no issues.

• Brand Name: ROCHESTER MEC POP-ON M 30BX
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8410118
• Report Number: 1018233-2019-01240
• Device Sequence Number: 10860238
• Product Code: NNX
• UDI-Device Identifier: 00801741070549
• UDI-Public: (01)00801741070549
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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 Expiration Date: 04/28/2023
• Device Model Number: 32302
• Device Catalogue Number: 32302
• Device Lot Number: JUCS0037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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: Required Intervention