MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-10 for PRESOURCE SOP51AOKIQ manufactured by Cardinal Health 200, Llc.
[120099482]
Noted a small black spider in the tape portion of (b)(6) med ctr arthroscopy pack, exp date: 12/01/2019, lot# 946301 with manufacturing date: 06/23/2018. Noted when opening pack - contents discarded. A new set up for case used. Kept wrapper with spider encased for examination. Dates of use: (b)(6) 2018. The product was not compounded; the product was not over-the-counter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079694 |
| MDR Report Key | 7864466 |
| Date Received | 2018-09-10 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-08-30 |
| Date Added to Maude | 2018-09-11 |
| 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 |
| 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 | PRESOURCE |
| Generic Name | DRAPE, SURGICAL, ENT |
| Product Code | ERY |
| Date Received | 2018-09-10 |
| Catalog Number | SOP51AOKIQ |
| Lot Number | 946301 |
| Device Expiration Date | 2019-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-10 |