MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for SKYN manufactured by Suretex Prophylactics (i), Ltd.
[72728526]
On (b)(6) 2017: user contacted customer service that since using skyn polyisoprene condoms, she has had three urinary tract infections from (b)(6) 2017. Customer indicated that they sought medical attention and was prescribed an antibiotic each time.
Patient Sequence No: 1, Text Type: D, B5
[76776916]
On 06/05/5017 - investigation record: device history record for the product reviewed. All manufacturing, in process and final testing indicates no deviations from specification. Retain samples sent to external lab for evaluation. Microbiological results indicate all criteria passed. Aqueous extractable protein evaluation indicate results within specified limits. Customer returned samples evaluated by external lab for micro and the results were within specification. No assignable cause identified. No corrective action applicable. Investigation closed
Patient Sequence No: 1, Text Type: N, H10
[76776917]
On 04/10/2017: user contacted customer service that since using skyn polyisoprene condoms, she has had three urinary tract infections from (b)(6) 2017. Customer indicated that they sought medical attention and was prescribed an antibiotic each time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00007 |
| MDR Report Key | 6489802 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-04-10 |
| Date Facility Aware | 2017-04-11 |
| Report Date | 2017-04-13 |
| Date Reported to FDA | 2017-04-13 |
| Date Reported to Mfgr | 2017-04-13 |
| Date Added to Maude | 2017-04-13 |
| 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 | MALE LUBRICATED POLYISOPRENE CONDOM |
| Product Code | MOL |
| Date Received | 2017-04-13 |
| Returned To Mfg | 2017-05-19 |
| Lot Number | 1511P20922 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX PROPHYLACTICS (I), LTD |
| Manufacturer Address | 74-91 KIADB ESTATE JIGANI II PHASE, ANEKAL TALUK BANGALORE KARNATAKA, 562106 IN 562106 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-13 |