MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-13 for SKYN 164672 manufactured by Suretex Prophylactics (i), Ltd..
[99907782]
On (b)(6) 2018 consumer indicated that they used skyn elite polyisoprene condom and believed that they developed a urinary tract infection. Visit to doctor was done and a uti was confirmed.
Patient Sequence No: 1, Text Type: D, B5
[126295345]
On 04/10/2018 the device history record (dhr) of the lots were analyzed with respect to the reported complaint. The lots were produced using synthetic polyisoprene with existing compounding formulation and there is no change in dosage or change of raw materials and chemicals used. And also there is no change in chemicals used in various stage of manufacturing process. The lots were inspected at various stages of manufacturing process & released as per the documented quality plan. No deviations identified. No root cause can be assigned. Record closed.
Patient Sequence No: 1, Text Type: N, H10
[126295346]
On (b)(6) 2018 consumer indicated that they used skyn elite polyisoprene condom and believed that they developed a urinary tract infection. Visit to doctor was done and a uti was confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013388459-2018-00003 |
| MDR Report Key | 7266332 |
| Date Received | 2018-02-13 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-01-26 |
| Date Facility Aware | 2018-01-26 |
| Report Date | 2018-02-13 |
| Date Reported to FDA | 2018-02-13 |
| Date Reported to Mfgr | 2018-02-13 |
| Date Added to Maude | 2018-02-13 |
| 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 | SKYN |
| Generic Name | POLYISOPRENE MALE CONDOM |
| Product Code | MOL |
| Date Received | 2018-02-13 |
| Returned To Mfg | 2018-02-12 |
| Catalog Number | 164672 |
| Lot Number | 1610P20722 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX PROPHYLACTICS (I), LTD. |
| Manufacturer Address | 74-91 KIADB INDUSTRIAL ESTATE JIGANI II PHASE,ANEKAL TALUK BANGALORE KARNATAKA, IN-KA 560 105 IN 560 105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-13 |