MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-04-10 for K-Y BRAND JELLY NI manufactured by Skillman Contract.
[2582102]
This spontaneous report was received by a (b)(6) johnson affiliate on (b)(6) 2012, from a consumer reporting on self from (b)(6). The medical history included an unspecified thyroid problem for an unspecified duration and a hysterectomy in 2011. The concomitant medications were not reported on an unspecified date in 2011, the consumer started using an unspecified amount of k-y brand jelly topically for general lubrication (lot number, frequency and expiration date unspecified) after having undergone a hysterectomy. After an unspecified duration, the consumer developed a bladder infection and could not void urine and when she did it was blood colored. The consumer was hospitalized for an unspecified duration. The medical treatment given in the hospital was not specified. The use of the product was discontinued on an unspecified date and the outcome of the events were recovered. This report was assessed as serious (medically significant). The company causality was assessed as possible.
Patient Sequence No: 1, Text Type: D, B5
[2606615]
This spontaneous report was received by a (b)(4) johnson & johnson affiliate on (b)(6) 2012, from a consumer reporting on self from (b)(4). The medical history included an unspecified thyroid problem for an unspecified duration and a hysterectomy in 2011. The concomitant medications were not reported on an unspecified date in 2011 the consumer started using an unspecified amount of k-y brand jelly topically for general lubrication (lot number, frequency and expiration date unspecified) after having undergone a hysterectomy. After an unspecified duration, the consumer developed a bladder infection and could not void urine and when she did it was blood colored. The consumer was hospitalized for an unspecified duration. The medical treatment given in the hospital was not specified. The use of the product was discontinued on an unspecified date and the outcome of the events were recovered. This report was assessed as serious (medically significant). The company causality was assessed as possible. Additional information received on (b)(6) 2012: the quality investigation was concluded on (b)(6) 2012, and no quality related issues have been identified that would warrant further quality investigation. The customer did not report a specific product or lot number for investigation; therefore lot trending could not be performed. A review of the complaint data associated with this complaint category revealed that there is one other adverse event "other" genital/anal/reproductive complaint reported for k-y jelly. A review of the complaint data associated with this complaint category did not identify any recent adverse trend for this product within the past 24 months. This report remains serious (medically significant) and the company causality was assessed as possible.
Patient Sequence No: 1, Text Type: D, B5
[9857810]
This is a foreign follow up report that is being submitted as a serious injury for a product that is same/similar to a us marketed product. The date of this submission is (b)(4) 2012. This report is being submitted to correct the follow up manufacturer report number previously submitted on (b)(4) 2012, from 2214133-2012-00014 to 2214133-2012-00002. This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
[9894181]
This is a foreign report that is being submitted as a serious injury for a product that is same/similar to a us marketed product. The date of this submission is (b)(6) 2012. This report is being submitted to correct the initial manufacturer report number previously submitted on (b)(6) 2012, from 2214133-2012-00014 to 2214133-2012-00002. This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2214133-2012-00002 |
| MDR Report Key | 2525327 |
| Report Source | 01 |
| Date Received | 2012-04-10 |
| Date of Report | 2012-01-03 |
| Date Mfgr Received | 2012-01-19 |
| Date Added to Maude | 2012-04-10 |
| 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 | 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 JELLY |
| Generic Name | LUBRICANT, PATIENT |
| Product Code | KMJ |
| Date Received | 2012-04-10 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| 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. Hospitalization; 2. Required No Informationntervention | 2012-04-10 |