MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for SPECIFIC/TOTAL IGE EIA 74115 manufactured by Hycor Biomedical.
[90745470]
The distributor did not open the boxes to determine what if anything was leaking or if the apparent damage to the outer carton was caused by an outside source. Product was shipped "as is" to their customer. Hycor attempted to investigate the reported issue further by requesting additional details, but none were provided, except images of the damaged boxes exhibiting water marks and damaged to shipping cartons. Our follow-up efforts have been exhausted as we were unable to determine whether the stop solution was the liquid found by the distributor. Furthermore, there were no reported adverse outcomes to hycor. However, given that the 1n sodium hydroxide solution can cause caustic burns to the skin, eyes, and respiratory system per safety data sheet (sds) #601a. 07, as an abundance of caution, hycor has opted to file an mdr? Internal reference: (b)(4). The reason this mdr is filed so late is because hycor went through an organizational change in january 2017 and the person who originally set up hycor's emdr certificates registered under his own name and not a general hycor account. We had to re-assign the certificate to hycor and go through the gateway validation process and we ran into technical issues with the validation process. Then fda updated the emdr software that caused us to have to start the validation process over. We had several interactions with the emdr help desk and we were finally able to complete the whole emdr gateway validation process this past week and can now file emdrs. We spoke with (b)(4) on march 31, 2017 and he instructed us to add our late explanation here. We offered to file a paper copy on march 31st but (b)(4) stated that the only option was to file emdrs now.
Patient Sequence No: 1, Text Type: N, H10
[90745471]
The distributor reported the shipment containing stop solution (1n sodium hydroxide) was received damaged as the pallet containing the shipping cartons with product was wet. We were not able to determine if there was an actual leak of stop solution or if the shipping cartons had gotten wet by another means (e. G. Condensation, water spill, etc. ) there were no adverse outcomes reported to hycor. However, out of an abundance of caution, we are filing an mdr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016473-2017-00001 |
| MDR Report Key | 6965064 |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-20 |
| Date of Event | 2017-03-15 |
| Date Mfgr Received | 2017-03-15 |
| Device Manufacturer Date | 2016-09-30 |
| Date Added to Maude | 2017-10-20 |
| 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 | MS. TARA VIVIANI |
| Manufacturer Street | 7272 CHAPMAN AVE |
| Manufacturer City | GARDEN GROVE CA 92841 |
| Manufacturer Country | US |
| Manufacturer Postal | 92841 |
| Manufacturer Phone | 7149333027 |
| Manufacturer G1 | HYCOR BIOMEDICAL |
| Manufacturer Street | 7272 CHAPMAN AVE |
| Manufacturer City | GARDEN GROVE CA 92841 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92841 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPECIFIC/TOTAL IGE EIA |
| Generic Name | SPECIFIC/TOTAL IGE EIA |
| Product Code | DHB |
| Date Received | 2017-10-20 |
| Catalog Number | 74115 |
| Lot Number | 154104-4 |
| Device Expiration Date | 2018-09-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYCOR BIOMEDICAL |
| Manufacturer Address | 7272 CHAPMAN AVE GARDEN GROVE CA 92841 US 92841 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |