MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-18 for DUREX PLEASURE RING 5011417565162 manufactured by Reckitt Benckiser Healthcare Int Limited.
[75503844]
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.
Patient Sequence No: 1, Text Type: N, H10
[75503845]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009722622-2017-00004 |
| MDR Report Key | 6577135 |
| Date Received | 2017-05-18 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-05-01 |
| Date Mfgr Received | 2017-05-05 |
| Date Added to Maude | 2017-05-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JOANNE MARTINEZ |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HULL HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| Manufacturer Phone | 97340 |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT LIMITED |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HULL HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU8 7DS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DUREX PLEASURE RING |
| Generic Name | DEVICE, EXTERNAL PENILE RIGIDITY |
| Product Code | LKY |
| Date Received | 2017-05-18 |
| Model Number | 5011417565162 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER HEALTHCARE INT LIMITED |
| Manufacturer Address | DANSOM LANE HULL, HULL HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-18 |