MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-01 for MEDICHOICE 006304 manufactured by .
[26693720]
Lubricating jelly tube opened. Appearance of jelly yellow instead of clear. After squeezing tube more, a black bug came out of the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5096478 |
| MDR Report Key | 5096478 |
| Date Received | 2004-12-01 |
| Date of Report | 2004-11-30 |
| Date of Event | 2004-11-26 |
| Date Facility Aware | 2004-11-26 |
| Report Date | 2004-11-30 |
| Date Reported to FDA | 2004-11-30 |
| Date Added to Maude | 2015-09-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDICHOICE |
| Generic Name | LUBRICATING JELLY 40G |
| Product Code | KMJ |
| Date Received | 2004-12-01 |
| Returned To Mfg | 2004-11-30 |
| Catalog Number | 006304 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-01 |