MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-30 for LIFESTYLES SILKY SMOOTH PERSONAL LUBRICANT manufactured by Ids Manufacturing Co,.ltd.
[71323039]
On (b)(6) 2017 - tested factory retain samples, checked dhr/production records and also tested the returned sample (unused from stock). All test results showed no abnormality and all were within product release specifications. Lubricant also contains no banana or orange extract. No root cause was identifiable and could be due to user's existing sensitivities. No further action can be taken at this time. The reporting of this event was due to a us equivalent product available in the us (lifestyles 2 in 1 personal lubricant). No similar events have been reported to date in the us market for this product.
Patient Sequence No: 1, Text Type: N, H10
[71323040]
On (b)(6) 2017 incident occured in (b)(6) with an (b)(4) product variant. Customer states that partner has had two incidents of reaction after using ansell lifestyles silky smooth lubricant. The first reaction was "stinging pain" that went away after a couple of days. The second reaction caused very intense stinging pain requiring the partner to go to the hospital for treatment. She was treated for an allergic reaction (medication prescribed unknown) and she was released after 5-6 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00006 |
| MDR Report Key | 6447390 |
| Date Received | 2017-03-30 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-02-22 |
| Date Facility Aware | 2017-02-22 |
| Report Date | 2017-03-30 |
| Date Reported to FDA | 2017-03-30 |
| Date Reported to Mfgr | 2017-03-08 |
| Date Added to Maude | 2017-03-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESTYLES SILKY SMOOTH PERSONAL LUBRICANT |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2017-03-30 |
| Returned To Mfg | 2017-03-13 |
| Lot Number | 16100104DR |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IDS MANUFACTURING CO,.LTD |
| Manufacturer Address | 21/7 LIABKWANGSONG VILLAGE NO 6 LAMLUKKA PATHUM THANI, 12130 TH 12130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-30 |