MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-24 for MARATHON NO STING CYANOACRYLATE SKIN PROTECTANT MSC093005 manufactured by Medline.
[81188819]
A (b)(6) premature infant was transferred from (b)(6) to (b)(6) hospital on thursday (b)(6) 2017. Upon arrival at (b)(6), the pt had a head to toe assessment, at that time, an area on the baby's back where ucsd had applied the product "medline skin wound care marathon no sting cyanoacrylate skin protectant" was cultured and subsequently grew aspergillus (species to be determined). The product had been used in other nicu and was trialed for 1 week at (b)(6) with no adverse outcomes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071243 |
| MDR Report Key | 6743776 |
| Date Received | 2017-07-24 |
| Date of Report | 2017-07-24 |
| Date of Event | 2017-07-21 |
| Date Added to Maude | 2017-07-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| 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 | 0 |
| Brand Name | MARATHON NO STING CYANOACRYLATE SKIN PROTECTANT |
| Generic Name | BANDAGE LIQUID |
| Product Code | KMF |
| Date Received | 2017-07-24 |
| Catalog Number | MSC093005 |
| Lot Number | P00206351 |
| Device Expiration Date | 2018-09-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-24 |