MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-26 for EZ- LUBRICATING JELLY 000304 manufactured by Chester Labs, Inc..
[16797076]
A physician's office reported that one patient experienced an allergic reaction on two separate occasions. The incidents occurred at different locations and an attempt was made to identify a potential source of the allergic response. A root cause was not confirmed but use of the lubricating jelly was common to both incidents. The first incident occurred in the office and was minor. The second reaction occurred during a colonoscopy and the pt developed itching, hives, swelling of the throat and shortness of breath. The symptoms resolved and it is not known if any medical intervention was initiated. The pt has known allergies to bee stings and various medications including but not limited to penicillin and possibly sulfa. No lot number was available for either product used. The patient is currently being followed by allergist. The patient's physicians have not confirmed the lube jelly caused or contributed to the allergic reaction but in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: D, B5
[17049742]
Patient is seeing an allergist who wanted more info about ez lube jelly and that is why the physician's office contacted us. They requested literature, package info, and an ingredient statement. Chester packaging's customer service department forwarded a list of ingredients. In addition, an ingredient statement with package used instructions was also sent to the physician's office. The patient's allergist and physician's office have not confirmed that the lube jelly caused or contributed to the incident but chester packaging is filing this report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022110-2014-00001 |
| MDR Report Key | 3731352 |
| Report Source | 05,06 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-03-25 |
| Date Mfgr Received | 2014-03-06 |
| Date Added to Maude | 2014-04-08 |
| 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., SUITE A |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5134583840 |
| Manufacturer G1 | CHESTER LABS, INC. |
| Manufacturer Street | 1900 SECTION RD., SUITE A |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ- LUBRICATING JELLY |
| Generic Name | LUBRICATING JELLY |
| Product Code | KMJ |
| Date Received | 2014-03-26 |
| Model Number | 000304 |
| Catalog 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 LABS, INC. |
| Manufacturer Address | 1900 SECTION RD., SUITE A CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-26 |