MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-06-11 for K-Y BRAND PRODUCTS KYGENRUS manufactured by Skillman Contract.
[3667989]
This spontaneous report was received on (b)(6) 2013, from a male consumer (age unspecified) reporting on self from the united states. The medical history and the concomitant medications were not reported. On an unspecified date, the consumer started using (b)(4) unspecified, topically for lubrication (lot number, expiration date, dose and frequency unspecified). After an unspecified duration, he experienced irritation. After an unspecified duration, he again used the same device and experienced irritation, redness, burning sensation and dryness on genital area. He developed a chemical burn and his skin came off. He also stated that his tongue skin tore off and throat swelled up. He stated that the package did not contain warning label that the device might cause chemical burn or skin to come off. The action taken with the device was unknown. The events did not resolve. Consumer did not report a specific product name or lot number. A review of the trending data for complaint revealed an increase in complaint volume. Since specific product names were not reported, it was not possible to determine which (b)(4) product had contributed to the increase in complaint volume. Complaint trend monitoring would continue. This report was assessed as serious (medically significant). The company causality was assessed as possible. Additional information received on (b)(6) 2013. Based on the information available, the device was used as intended for treatment. No further investigation required. No adverse trends were identified during the complaint investigation. Complaint trends would continue to be monitored. This report remains serious.
Patient Sequence No: 1, Text Type: D, B5
[10958569]
This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
[19197031]
This spontaneous report was received on (b)(6) 2013, from a male consumer (age unspecified) reporting on self from the united states. The medical history and the concomitant medications were not reported. On an unspecified date, the consumer started using k-y unspecified, topically for lubrication (lot number, expiration date, dose and frequency unspecified). After an unspecified duration, he experienced irritation. After an unspecified duration, he again used the same device and experienced irritation, redness, burning sensation and dryness on genital area. He developed a chemical burn and his skin came off. He also stated that his tongue skin tore off and throat swelled up. He stated that the package did not contain warning label that the device might cause chemical burn or skin to come off. The action taken with the device was unknown. The events did not resolve. Consumer did not report a specific product name or lot number. A review of the trending data for complaint revealed an increase in complaint volume. Since specific product names were not reported, it was not possible to determine which k-y product had contributed to the increase in complaint volume. Complaint trend monitoring would continue. This report was assessed as serious (medically significant). The company causality was assessed as possible.
Patient Sequence No: 1, Text Type: D, B5
[19468247]
(b)(4). This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2013-00045 |
| MDR Report Key | 3161396 |
| Report Source | 04 |
| Date Received | 2013-06-11 |
| Date of Report | 2013-05-13 |
| Date Mfgr Received | 2013-07-22 |
| Date Added to Maude | 2013-06-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMAL YAMANY |
| Manufacturer Street | 199 GRANDVIEW ROAD NI |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089043455 |
| Manufacturer G1 | SKILLMAN CONTRACT |
| Manufacturer Street | 199 GRANDVIEW ROAD NI |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08558 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y BRAND PRODUCTS |
| Generic Name | PERSONAL LUBRICANT |
| Product Code | KMJ |
| Date Received | 2013-06-11 |
| Model Number | KYGENRUS |
| Catalog Number | NI |
| Lot Number | N/A |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKILLMAN CONTRACT |
| Manufacturer Address | 199 GRANDVIEW ROAD NI SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-11 |