MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-03-07 for LUBE JELLY manufactured by .
[1958516]
Phone call received (b)(6) 2011 about recall of lube jelly. She has been on antibiotics due to infections. She will be returning to the doctor this week.
Patient Sequence No: 1, Text Type: D, B5
[9221774]
Consumer said she would call back after doctor visit and no return phone call with permission to speak to the doctor (b)(6) given. We need to get the following information to complete the investigation and permission to get information from the doctor. Product code and lot #, any returned samples, copies of any test results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2128643-2011-00005 |
| MDR Report Key | 2020206 |
| Report Source | 04 |
| Date Received | 2011-03-07 |
| Date of Report | 2011-03-03 |
| Date Mfgr Received | 2011-02-15 |
| Date Added to Maude | 2012-05-24 |
| 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 | KRISTI BONAPARTE |
| Manufacturer Street | 700 NORTH SHORE DRIVE |
| Manufacturer City | HARTLAND WI 53029 |
| Manufacturer Country | US |
| Manufacturer Postal | 53029 |
| Manufacturer Phone | 2625382900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LUBE JELLY |
| Product Code | FHX |
| Date Received | 2011-03-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-07 |