MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-25 for SKYN ELITE CONDOM 7210 manufactured by Suretex Prophylactics (i), Ltd..
[83730432]
On (b)(6)2017 - a retail business in (b)(6) advised that it received us labeled stock of skyn elite polyisoprene condom along with (b)(4) labeled product. The us label is not compliant with health (b)(4) labeling requirements and is being recalled in (b)(4). As the event is (b)(6) specific but a recall of a product sold in the us, this report is being submitted. Non us product is impacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00012 |
| MDR Report Key | 6821488 |
| Date Received | 2017-08-25 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-08-21 |
| Date Facility Aware | 2017-08-24 |
| Report Date | 2017-12-06 |
| Date Reported to FDA | 2017-12-06 |
| Date Added to Maude | 2017-08-25 |
| 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 | 0 |
| Brand Name | SKYN ELITE CONDOM |
| Generic Name | POLYISOPRENE MALE LATEX CONDOM |
| Product Code | MOL |
| Date Received | 2017-08-25 |
| Model Number | 7210 |
| Device Availability | N |
| Device Age | 6 MO |
| 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. Other | 2017-08-25 |