MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT LIMITED DUREX PLEASURE RING; DEVICE, EXTERNAL PENILE RIGIDITY

Model Number	5011417565162
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Nerve Damage (1979); Hypoesthesia (2352); Nerve Proximity Nos (Not Otherwise Specified) (2647)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident.The patient did specify the variety of durex that was used as durex pleasure ring.The patient neither provides the batch details for the product nor returned any of the remaining unopened product for quality analysis.Further information is expected.The product labelling also states that "if using this ring feels uncomfortable or hurts, stop and take it off.Store it in a cool, dry place away from direct sunlight." the company's assessment is serious with a relatedness of possible.
Event or Problem Description
Initial report, received date: 05-may-2017.Received from consumer relations, country: (b)(6).Batch no and expiry date: not provided.Case reference number (b)(4) is a report sent by a consumer which refers to a male age unknown.It was reported that on (b)(6) 2017 (3 days before reporting), a male patient of an unknown age used durex pleasure ring.He said after 10-15 minutes of using product, he had lost any feelings in his penis and his erection had disappeared.He has all medical documents from hospital that can confirm that after using product, nerves in his penis were damaged.He needed to undergo long-term treatment.He said that at this moment doctors could not tell him if he would ever recover.The company's assessment is serious with a relatedness of possible and unanticipated.Case outcome: not recovered / not resolved.

• Brand Name: DUREX PLEASURE RING
• Common Device Name: DEVICE, EXTERNAL PENILE RIGIDITY
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, hull HU8 7 DS; UK HU8 7DS
• MDR Report Key: 6577135
• Report Number: 3009722622-2017-00004
• Device Sequence Number: 1082320
• Product Code: LKY
• UDI-Device Identifier: 00067981957525
• UDI-Public: 00067981957525
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2017

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 Model Number: 5011417565162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/18/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other