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 E-Z LUBRICATING JELLY. 000304 manufactured by Chester Packaging.
[16220538]
Patient developed an immediate reaction after an anoscope test where a scope is inserted in the anus. The patient's reaction was anaphylaxis. Reaction symptoms began about ten minutes after the procedure and involved facial swelling and redness, lip swelling. The patient used a self-prescribed antihistamine, xyzal that he carried with him. He also carries an epi pen but did not use it. His symptoms resolved after taking the medication. The patient has a known allergy to polyethylene glycol which is an ingredient in the e-z lubricating jelly. A product ingredient statement and msds was requested.
Patient Sequence No: 1, Text Type: D, B5
[16249965]
The patient had a known allergy to polyethylene glycol which is an ingredient in e-z lubricating jelly which was the root cause for the reported reaction. The patient used a self-prescribed antihistamine, zyzal, and his symptoms resolved after taking the medication. He was discharged without further complications. The nurse requested and received a copy of the lubricating jelly ingredient statement and an msds.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022110-2013-00002 |
| MDR Report Key | 3281685 |
| Report Source | 05 |
| Date Received | 2013-08-03 |
| Date of Report | 2013-07-31 |
| Date of Event | 2013-07-18 |
| Date Mfgr Received | 2013-07-16 |
| Date Added to Maude | 2013-08-13 |
| 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 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 LUBRICATING JELLY. |
| Product Code | KMJ |
| Date Received | 2013-08-03 |
| Model Number | 000304 |
| Lot Number | UNK |
| 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 |