MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-08-07 for CTR000302 manufactured by Medline Industries Inc..
[116217328]
It was reported that the patient experienced an anaphylactic reaction from the lubricating jelly that was used during a prostate biopsy. Reportedly, during the procedure the patient experienced nausea, lightheadedness, and disorientation. After the procedure was completed, the patient experienced a syncopal episode with facial laceration and "hives over his entire body and also had throat and mouth swelling with shortness of breath. " the patient reportedly went to a local hospital emergency department (ed) where he received an unknown number of sutures for his facial laceration, iv benadryl, and an unidentified steroid. No ed diagnostics reported. No additional ed treatments reported. It was not identified if the patient was admitted to the hospital after the ed visit. No sample was returned to the manufacturer for evaluation. A root cause could not be determined. Due to the reported incident, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[116217329]
It was reported that the patient experienced an anaphylactic reaction and a syncopal episode with facial laceration after use of the lubricating jelly for a prostate biopsy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00082 |
| MDR Report Key | 7756354 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-07-25 |
| Date Added to Maude | 2018-08-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | JELLY,LUBE,STRL,FLIP TOP,TUBE,2 OZ |
| Product Code | KMJ |
| Date Received | 2018-08-07 |
| Catalog Number | CTR000302 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-07 |