MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-03 for SKYN 7312 manufactured by Suretex Prophylactics (i), Ltd..
[96225177]
No further information was provided at the time to the severity of the reaction, type of reaction, and whether treatment was sought; follow up inquiries were made to the customer for more information. On (b)(6) 2017 customer responded that they went to a urologist and was prescribed a medication for treatment. No details to the medication prescribed were given.
Patient Sequence No: 1, Text Type: N, H10
[96225178]
On (b)(6) 2017 customer indicated that he experienced a reaction after use of the product. No further information was provided at the time to the severity of the reaction, type of reaction, and whether treatment was sought; follow up inquiries were made to the customer for more information. On (b)(6) 2017 customer responded that they went to a urologist and was prescribed a medication for treatment. No details to the medication prescribed were given.
Patient Sequence No: 1, Text Type: D, B5
[126294991]
No further information was provided at the time to the severity of the reaction, type of reaction, and whether treatment was sought; follow up inquiries were made to the customer for more information. On (b)(6) 2017 customer responded that they went to a urologist and was prescribed a medication for treatment. No details to the medication prescribed were given. On 02/13/2018 review of device history record conducted. Customer returned samples tested for visual and lubricant quantity. No deviation or assignable cause could be determined from assessment. No further corrective action can be assigned at this time.
Patient Sequence No: 1, Text Type: N, H10
[126294992]
On (b)(6) 2017 customer indicated that he experienced a reaction after use of the product. No further information was provided at the time to the severity of the reaction, type of reaction, and whether treatment was sought; follow up inquiries were made to the customer for more information. On (b)(6) 2017 customer responded that they went to a urologist and was prescribed a medication for treatment. No details to the medication prescribed were given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013388459-2018-00001 |
| MDR Report Key | 7159746 |
| Date Received | 2018-01-03 |
| Date of Report | 2018-02-13 |
| Date of Event | 2017-11-21 |
| Date Facility Aware | 2017-11-21 |
| Report Date | 2018-01-03 |
| Date Reported to FDA | 2018-01-03 |
| Date Reported to Mfgr | 2018-01-03 |
| Date Added to Maude | 2018-01-03 |
| 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 | SKYN |
| Generic Name | POLYISOPRENE LATEX MALE CONDOM |
| Product Code | MOL |
| Date Received | 2018-01-03 |
| Returned To Mfg | 2018-01-02 |
| Model Number | 7312 |
| Lot Number | 1608P40122 |
| 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 | 2018-01-03 |