MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2015-03-09 for ISCREEN OFD SALIVA TEST DSB-765-011-ONW510 manufactured by Abon Biopharm (hangzhou) Co., Ltd.
[15896469]
Customer alleged an allergic reaction from using the iscreen ofd saliva test. Results as follows: the distributor reported that the end-user had a donor that had an allergic reaction after using the iscreen ofd saliva test. The donor reports that he is allergic to corn syrup. The donor had gone home after using the oral-fluid test and called the test provider back after about 30 minutes because his face started to swell. The donor asked if the test collectors had corn syrup in them. The donor was reported to have taken benadryl and was doing okay. Kit was purchased in (b)(6) 2014. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
[16214937]
Note: this product is for forensic use only and therefore is 510(k) exempt. Investigation: customer's observation could not be reproduced with in-house retain product. In-house retain product were tested with drug free donors, the test results did not observed any abnormal, including sponge color, smell, device appearance etc. Per issue, "donor is allergic to corn syrup", due to sponge's treatment procedures, it did not have corn syrup component in sponge. Sponge was treated with sucrose which shares a common component with corn syrup. Both corn syrup and sucrose contain glucose. It cannot be ruled out that this ingredient may have caused the patient's allergic reaction. This issue will be tracked and trended. Corrective action is not required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2015-00167 |
| MDR Report Key | 4583938 |
| Report Source | 07,08 |
| Date Received | 2015-03-09 |
| Date of Report | 2015-02-13 |
| Date of Event | 2015-02-13 |
| Date Mfgr Received | 2015-02-13 |
| Date Added to Maude | 2015-04-08 |
| 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 Contact | CECILLE MICIANO |
| Manufacturer Street | 1342 COURT STREET |
| Manufacturer City | PORTSMOUTH VA 23704 |
| Manufacturer Country | US |
| Manufacturer Postal | 23704 |
| Manufacturer Phone | 7573986150 |
| Manufacturer G1 | ABON BIOPHARM (HANGZHOU) CO., LTD |
| Manufacturer Street | #198 12TH STREET EAST HANGZHOU ECON & TECH DEV AREA |
| Manufacturer City | HANGZHOU, ZHEJIANG ZHEJIANG 310018 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 310018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISCREEN OFD SALIVA TEST |
| Generic Name | DRUGS OF ABUSE TEST |
| Product Code | MVO |
| Date Received | 2015-03-09 |
| Model Number | DSB-765-011-ONW510 |
| Lot Number | DOA3090278 |
| Device Expiration Date | 2015-07-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABON BIOPHARM (HANGZHOU) CO., LTD |
| Manufacturer Address | #198 12TH STREET EAST HANGZHOU ECON & TECH DEV AREA HANGZHOU, ZHEJIANG ZHEJIANG 310018 CH 310018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-09 |