MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2015-04-22 for E-Z LUBE JELLY 000303 manufactured by Readycare Cincinatti.
[5585579]
It was reported that patient experienced 3 uti's in a 2 month period.
Patient Sequence No: 1, Text Type: D, B5
[13229741]
Lube jelly is used 3 times daily during catheterization procedures. Individual packets of lube jelly are used for each catheterization. A 12 french coude tip sterile catheter is used. There is no indwelling catheter. This patient has required this procedure since he was 1 years old. He is a quadraplegic due to transverse myelitis. He has a spastic bladder and is treated with ditropan. He was diagnosed with 3 uti's in less that 2 months and was treated with antibiotics. Th root cause of the uti's was not determined. Unused samples from the same lot were returned for evaluation. Microbial testing was performed on those, as well as on retained unsterile samples from the same production lot. Al samples met specifications with no growth recovered. We have no information to suggest the lubricating jelly was a cause or contributing factor to the reported incident. The mother of the patient is looking at other products they use that could be possible contributing factors to the infections, including but not limited to, the catheter and gloves.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022110-2015-00002 |
| MDR Report Key | 4730738 |
| Report Source | 04,08 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-04-20 |
| Date of Event | 2015-03-31 |
| Date Mfgr Received | 2015-03-24 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-04-28 |
| 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 | 0 |
| Manufacturer Contact | SHERRI WEEMS-CHRISTIE |
| Manufacturer Street | 1900 SECTION RD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5134583840 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-Z LUBE JELLY |
| Generic Name | LUBRICATING JELLY |
| Product Code | KMJ |
| Date Received | 2015-04-22 |
| Returned To Mfg | 2015-04-02 |
| Catalog Number | 000303 |
| Lot Number | 972129 |
| Device Expiration Date | 2016-05-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | READYCARE CINCINATTI |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-22 |