MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-02-20 for E-Z LUBRICATING JELLY UNK manufactured by Chester Packaging.
[5541402]
It was reported that a pt suffered severe allergic reaction to an ingredient in the lubricating jelly during a colonoscopy.
Patient Sequence No: 1, Text Type: D, B5
[12844365]
A pt with known severe sensitivity to peg underwent a colonoscopy on (b)(6) 2013. The lubricating jelly, which contains peg, was used during the procedure. The pt suffered a severe allergic reaction, causing him to go into cardiac arrest. He was defibrillated, given epinephrine and was admitted to the hospital. He underwent cardiac surgery and was placed on a ventilator. He was reported to have suffered brain damage due to oxygen deprivation. This incident had not been previously reported to us. We have no info to suggest the presence of any prod defect. The root cause has been determined to be an allergic reaction to the lubricating jelly. Due to the reported incident and need for medical/surgical intervention, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022110-2015-00001 |
| MDR Report Key | 4541899 |
| Report Source | 00 |
| Date Received | 2015-02-20 |
| Date of Report | 2015-02-19 |
| Date of Event | 2013-01-17 |
| Date Mfgr Received | 2015-01-30 |
| Date Added to Maude | 2015-02-25 |
| 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 | 5134583540 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-Z LUBRICATING JELLY |
| Generic Name | LUBRICATING JELLY |
| Product Code | KMJ |
| Date Received | 2015-02-20 |
| Catalog Number | UNK |
| 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 | 1900 SECTION RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-20 |