MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-12-21 for DUREX PLAY LUBRICANT STIMULATING manufactured by Reckitt Benckiser Healthcare Int. Limited.
[95583103]
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 product that was used as durex massage & play guarana lubricant. The patient neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis. No further information is expected, therefore the company is unable to conduct any further investigation at this moment in time. The product labelling states that if you experience irritation, stop using this lube. If irritation continues, see your doctor. The company's assessment for this case is serious and possible.
Patient Sequence No: 1, Text Type: N, H10
[95583104]
Patient had edema all over her inner thighs and vaginal area, pretty much anywhere the gel had touched [oedema]. Patient's vagina was swollen shut [vulvovaginal swelling]. Blisters [blister]. Patient was feeling a bit of burning in her pelvic region [burning sensation]. The edema was so severe, it made patient extremely difficult to urinate [dysuria] hives [urticaria]. The edema was so severe, it made patient extremely difficult to move [gait disturbance]. Patient had a severe skin reaction [skin reaction]. Patient woke with excruciating pain [pain]. Patient was feeling irritation in her pelvic region [skin irritation]. Patient missed a day of work because of excruciating pain and doctor visit [loss of personal independence in daily activities]. Case description: report no 1, received date: 27-nov-2017. Received from consumer relations, country: united states, reference no: (b)(4). Suspect product: durex massage and play guarana lubricant. Batch no. And expiry date: not provided. Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a female age unknown. It was reported by patient's partner that on an unknown date, their female partner of an unknown age used durex massage and play guarana lubricant; route, indication and duration all were unknown. Reporter stated that on an unknown date (day after using product), her partner was feeling a bit of burning and irritation in her pelvic region. Reporter stated that next morning she woke with excruciating pain. She ended up going into the doctor with a severe skin reaction. Reporter stated that there were blisters, hives and oedema all over her inner thighs and vaginal area, pretty much anywhere the gel had touched. Reporter stated that the oedema was so severe, it made it extremely difficult to urinate and move. Reporter stated that patient's vagina was swollen shut, sitting, standing and lying down were completely painful. Reporter stated that on an unknown date, the doctor had to administer a shot of antihistamine, put her on antihistamine tablets and antibiotics because of the reaction. Reporter stated that patient missed a day of work because of excruciating pain and doctor visit. Reporter stated that patient was at work and suffering tremendously. At the time of the report, the effects were ongoing. Treatment drug had been reported but it was unknown which event(s) was treated. The case was deemed serious because it was classed as medically significant. No further information was available at the time of report. Case assessment for durex massage and play guarana lubricant is as follows: the reported assessment has not been provided, case relatedness is possible. The company's assessment for the case is serious with a relatedness of possible and unanticipated case outcome: not recovered / not resolved. Case status: ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010164364-2017-00008 |
| MDR Report Key | 7140029 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date Mfgr Received | 2017-11-27 |
| Date Added to Maude | 2017-12-21 |
| 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 LAN |
| Manufacturer City | HULL, HULL HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| 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 | 3 |
| Brand Name | DUREX PLAY LUBRICANT STIMULATING |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2017-12-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-12-21 |