MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-12-30 for K-Y BRAND JELLY PERSONAL LUBRICANT KYJPNSUS manufactured by Skillman Contract.
[2369729]
This spontaneous report was received on (b)(6)-2011 from a female consumer (age unspecified) reporting on self from (b)(6). This was a foreign report for an international device that was being submitted as similar to a united states marketed device. The consumer had a known allergy (unspecified), controlled by epi-pen (epinephrine auto-injectors). The concomitant medications were not reported. On an unspecified date, about two weeks ago, the consumer used k-y brand jelly personal lubricant topically for lubrication (lot number, frequency and expiration date unspecified). After an unspecified duration, the consumer experienced genital burning sensation and developed possible anaphylactoid reaction presented as throat swelling and throat closing up. She treated the events with oral antihistamines. The action taken with the device and the outcome of the events were unknown. This report was assessed as serious (medically significant). The company causality was assessed as possible.
Patient Sequence No: 1, Text Type: D, B5
[9595467]
This event occurred in (b)(6), it is being reported as a same/similar device to a currently marketed us product. The device in this case is not made or imported into the us. The date of this submission is (b)(4)-2011. This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2011-00011 |
| MDR Report Key | 2392835 |
| Report Source | 01 |
| Date Received | 2011-12-30 |
| Date of Report | 2011-12-14 |
| Date Mfgr Received | 2011-12-14 |
| Date Added to Maude | 2011-12-30 |
| 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 | 3 |
| Health Professional | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-Y BRAND JELLY PERSONAL LUBRICANT |
| Generic Name | LUBRICANT, PATIENT |
| Product Code | KMJ |
| Date Received | 2011-12-30 |
| Model Number | KYJPNSUS |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| 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 | 2011-12-30 |