MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-05 for SKYN manufactured by Suretex Prophylactics (i), Ltd..
[96501172]
Customer experienced severe vaginal irritation necessitating trips to the doctor. Customer also states that there was a perfume smell to the condom.
Patient Sequence No: 1, Text Type: N, H10
[96501173]
On (b)(6) 2018 customer experienced severe vaginal irritation necessitating trips to the doctor. Customer also states that there was a perfume smell to the condom.
Patient Sequence No: 1, Text Type: D, B5
[112487253]
Customer experienced severe vaginal irritation necessitating trips to the doctor. Customer also states that there was a perfume smell to the condom. On 01/12/2018 - a review of the device history record indicated no deviation or out of specification result from the batch record. Retain samples from the same lot were evaluated for odor. No substantial mal odor was detected. No further assignable cause can be identified from the batch record. On 04/14/2018 - (b)(4) intact pieces sent back to the manufacturer. Testing os samples for odor met requirements. Testing for microbial evaluation for microbial count and total yeast and mold were below limit and test for 5 bacteria showed absence. No root cause can be attributed and with the original investigation, all performance and release criteria met specification. No further action to be taken.
Patient Sequence No: 1, Text Type: N, H10
[112487254]
(b)(6) 2018 customer experienced severe vaginal irritation necessitating trips to the doctor. Customer also states that there was a perfume smell to the condom.
Patient Sequence No: 1, Text Type: D, B5
[126294456]
Customer experienced severe vaginal irritation necessitating trips to the doctor. Customer also states that there was a perfume smell to the condom. On 01/12/2018, a review of the device history record indicated no deviation or out of specification result from the batch record. Retain samples from the same lot were evaluated for odor. No substantial mal odor was detected. No further assignable cause can be identified from the batch record.
Patient Sequence No: 1, Text Type: N, H10
[126294457]
On (b)(6) 2018 customer experienced severe vaginal irritation necessitating trips to the doctor. Customer also states that there was a perfume smell to the condom.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013388459-2018-00002 |
| MDR Report Key | 7168223 |
| Date Received | 2018-01-05 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-01-03 |
| Date Facility Aware | 2018-01-03 |
| Report Date | 2018-01-12 |
| Date Reported to FDA | 2018-01-12 |
| Date Reported to Mfgr | 2018-01-12 |
| Date Added to Maude | 2018-01-05 |
| 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 | 2018-01-05 |
| Returned To Mfg | 2018-01-29 |
| Lot Number | 1706P30622 |
| 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 | 2018-01-05 |