MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-13 for SKYN NOT PROVIDED 115091 manufactured by Suretex Ltd.
[64779544]
On 01/13/2017 - customer indicated that in (b)(6), they purchased a skyn condom and after use, it caused irritation and scratching for the next 24 hours. Partner had no symptoms. After, discharge from vaginal area started. Customer indicated that they did not have purchase receipt or samples to provide.
Patient Sequence No: 1, Text Type: D, B5
[68788755]
On 03/02/2017 a review of the batch record indicated no deviations or out of spec results during in process or finished good release. Protein testing was conducted for batch produced; results show passed. No further root cause could be established and no further action can be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
[68788756]
(b)(6) 2017 - customer indicated that in (b)(6), they purchased a skyn condom and after use, it caused irritation and scratching for the next 24 hours. Partner had no symptoms. After, discharge from vaginal area started. Customer indicated that they did not have purchase receipt or samples to provide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00003 |
| MDR Report Key | 6250549 |
| Date Received | 2017-01-13 |
| Date of Report | 2017-03-02 |
| Date of Event | 2016-12-20 |
| Report Date | 2017-01-13 |
| Date Reported to FDA | 2017-01-13 |
| Date Reported to Mfgr | 2017-03-02 |
| Date Added to Maude | 2017-01-13 |
| 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 LATEX CONDOM |
| Product Code | MOL |
| Date Received | 2017-01-13 |
| Returned To Mfg | 2017-01-20 |
| Model Number | NOT PROVIDED |
| Catalog Number | 115091 |
| Lot Number | 1412413316 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX LTD |
| Manufacturer Address | 31/1 MOO 4, TAMBON KHAO HUA KW AMPHUR PHUNPHIN SURATTHANI, SURAT THANI 84130 TH 84130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-13 |