MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-20 for LUBRICANT JELLY PACKETS EZ 00303 manufactured by Chester Packaging Llc.
[5753864]
Mom called in to find out if there have been any recalls on the lubricant jelly packets (there was one in 2011). I informed her that there currently is not a recall, and she informed me that since the beginning of (b)(6) 2015, patient has had 2 confirmed uti's and she is thinking he is getting another one currently. We decided that she should stop using the current packets and we sent out another box with a different lot number. Mom will contact me if patient has any further uti's. We are unsure if it is the lubricant jelly packets that are causing him to have uti's, but due to the recall in 2011, we decided to change to a different lot number of the same product to see if this helps. Mom uses sterile gloves and catheters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041685 |
| MDR Report Key | 4643392 |
| Date Received | 2015-03-20 |
| Date of Report | 2015-03-20 |
| Date of Event | 2015-03-20 |
| Date Added to Maude | 2015-04-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUBRICANT JELLY PACKETS EZ |
| Generic Name | LUBRICANT JELLY PACKETS EZ |
| Product Code | KMJ |
| Date Received | 2015-03-20 |
| Catalog Number | 00303 |
| Lot Number | 972129 |
| Device Expiration Date | 2016-05-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHESTER PACKAGING LLC |
| Manufacturer Address | CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-20 |