DUREX Play Prolong & Play Penile Rigidity RingRecalls & reported problems
RB Health (us) LLC · Penile Rigidity Ring · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 99067981957529), received between May 18, 2017 and Aug 7, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Operates Differently Than Expected1
Patient problems
- Hypoesthesia2
- Depression1
- Discomfort1
- Dysuria1
- Hemorrhage/Blood Loss/Bleeding1
- Nerve Damage1
- Nerve Proximity Nos (Not Otherwise Specified)1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEPRESSION [DEPRESSION], BLEEDING DURING AND POST DEFECATION [RECTAL HAEMORRHAGE], PATIENT STARTED FEELING PAIN / PAIN WAS MORE INTENSE IN TESTICLES, ANUS AND PENIS [GENITAL PAIN], LACK OF PENIS SENSITIVITY [HYPOAESTHESIA], DIFFICULTY TO KEEP IT AS WELL EJACULATION PROBLEMS [EJACULATION DISORDER], DECREASED URINE FLOW [URINE FLOW DECREASED], FLACCIDITY [HYPOTONIA], PATIENT STARTED FEELING DISCOMFORT FROM THE LOWER ABDOMEN TO THE PENIS, GLANS AND PERINEUM REGION. [DISCOMFORT]. CASE DESCRIPTION: INITIAL REPORT, DATE 10-JUL-2018. RECEIVED FROM CONSUMER RELATIONS, (B)(6), (B)(4). SUSPECT PRODUCT: DUREX PLEASURE RING BATCH NO: 0D6125216. EXPIRY DATE: NOT PROVIDED. CASE (B)(4) IS A SPONTANEOUS CASE REPORT SENT BY A CONSUMER WHICH REFERS TO A MALE AGE UNKNOWN. IT WAS REPORTED THAT ON (B)(6) 2017, A MALE PATIENT OF AN UNKNOWN AGE USED DUREX PLEASURE RING FOR APPROXIMATELY 20 MINUTES. AFTER USING IT HE STARTED FEELING PAIN AND DISCOMFORT FROM THE LOWER ABDOMEN TO THE PENIS, GLANS AND PERINEUM REGION. THE PAIN WAS MORE INTENSE IN HIS TESTICLES, ANUS AND PENIS. REPORTER ALSO STATED THAT DIFFERENT SYMPTOMS APPEARED DUE TO THE PAIN AND DISCOMFORT EXPLAINED BEFORE, SUCH AS; LACK OF PENIS SENSITI
Patient problems: Depression; Discomfort; Dysuria; Hemorrhage/Blood Loss/Bleeding; Hypoesthesia; Pain
MAUDE report 7759199 ↗InjuryMay 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
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 problems: Hypoesthesia; Nerve Damage; Nerve Proximity Nos (Not Otherwise Specified)
MAUDE report 6577135 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.