MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-03 for LIFESTYLES EXCITE GEL manufactured by Span Packaging Services D.b.a. Multi Pack Solution.
[56331804]
The 510k 021125.
Patient Sequence No: 1, Text Type: N, H10
[56331805]
After a report of (b)(6) from end user, ansell followed up to end user to get additional information on a product complaint. On (b)(6), end user indicated that they developed a rash after using the product. The end user consulted with a physician who indicated to use an over the counter product such as vaseline and hydrocortisone cream.
Patient Sequence No: 1, Text Type: D, B5
[58282370]
On (b)(6) 2016 customer did not retain product and could not provide a lot/batch number for ansell to check batch record information. No other adverse reports of this type have been reported to date.
Patient Sequence No: 1, Text Type: N, H10
[58282371]
After a report of (b)(6) from end user, ansell followed up to end user to get additional information on a product complaint. On (b)(6), end user indicated that they developed a rash after using the product. The end user consulted with a physician who indicated to use an over the counter product such as vasoline and hydrocortinsone cream.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2016-00009 |
| MDR Report Key | 5995176 |
| Date Received | 2016-10-03 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-09-23 |
| Date Facility Aware | 2016-09-23 |
| Report Date | 2016-10-03 |
| Date Reported to FDA | 2016-10-03 |
| Date Reported to Mfgr | 2016-10-03 |
| Date Added to Maude | 2016-10-03 |
| 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 EXCITE GEL |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | NUC |
| Date Received | 2016-10-03 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPAN PACKAGING SERVICES D.B.A. MULTI PACK SOLUTION |
| Manufacturer Address | 4611-A DAIRY DRIVE GREENVILLE SC 29607 US 29607 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-03 |