MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-03 for MEDICHOICE LUBRICATING JELLY 40672 OR 40674 manufactured by Chester Packaging.
[3842118]
Pt experienced a reaction to medichoice lubricating jelly during a pelvic exam. The reaction consisted of hives, swelling, and difficulty breathing within 15 minutes of exposure. She was given benadryl and taken to the er where she was given iv benadryl and steroids. The condition quickly improved and she was subsequently discharged. The doctor decided not to perform any further tests as the pt is in her (b)(6). No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[11136506]
The physician determined that the pt most likely had a sensitivity to parabens and this sensitivity was the root cause for the reported reaction. The doctor decided not to perform any further tests as the pt is in her (b)(6). They requested and received a copy of the lubricating jelly ingredient statement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022110-2013-00001 |
| MDR Report Key | 3330147 |
| Report Source | 05 |
| Date Received | 2013-08-03 |
| Date of Report | 2013-07-31 |
| Date of Event | 2013-06-26 |
| Date Mfgr Received | 2013-06-28 |
| Date Added to Maude | 2013-09-09 |
| 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 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 | MEDICHOICE LUBRICATING JELLY |
| Product Code | KMJ |
| Date Received | 2013-08-03 |
| Model Number | 40672 OR 40674 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHESTER PACKAGING |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-08-03 |