MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-07 for CANKER-X manufactured by Sinclair Pharma Srl.
[32839095]
The treatment was discontinued. The patient went to the emergency room and was admitted to the intensive care unit. Patient recovered. After receiving the customer complaint, the manufacturer performed a complete review of the process documentation of the manufactured lot. In addition they performed microbiological and chemical physical test on the retained samples both bulk and finish product, in order to check any deviation. Although the actual sample was not tested a retained sample from the same lot was checked with no issues identified. The documentation review and the sample retest confirmed that the product complies with the specification. In particular the microbiological and chemical physical analysis confirmed the compliance of the specs. (b)(4). This issue is likely to relate to an allergic reaction. Sinclair offered the patient to take an allergy test, however patient advised he did not want to perform such a test.
Patient Sequence No: 1, Text Type: N, H10
[32839096]
An adult male (approximately (b)(6) was treated with aloclair gel (same formula as canker-x in usa) for a blister on tongue. Patient experienced an allergic reaction, 40 minutes after application on blisters on tongue; the tongue started to swell 3-4 times its normal size.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001413787-2015-00001 |
| MDR Report Key | 5271695 |
| Date Received | 2015-12-07 |
| Date of Report | 2015-12-07 |
| Date of Event | 2015-10-08 |
| Date Facility Aware | 2015-12-01 |
| Report Date | 2015-12-07 |
| Date Reported to Mfgr | 2015-12-07 |
| Date Added to Maude | 2015-12-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANKER-X |
| Generic Name | DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC |
| Product Code | MGQ |
| Date Received | 2015-12-07 |
| Lot Number | 092541 |
| Device Expiration Date | 2018-03-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SINCLAIR PHARMA SRL |
| Manufacturer Address | VIALE RESTELLI AL N.5 MILANO LOMBARDIA, 20124 IT 20124 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-12-07 |