MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for MICROTEK 1 3981 manufactured by Microtek Medical, Inc..
[143977721]
Appears to be manufacturing defect in placement of instructional diagram for sterile application. Ecolab microtek shoulder arthroscopy drape ref #(b)(4), lot #d183304 was designed so that when you drape the lower part of the body, the adhesive part of the drape is on the wrong side. If you use the diagram on the drape - you are placing upside down
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8577310 |
| MDR Report Key | 8577310 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-04-10 |
| Report Date | 2019-04-16 |
| Date Reported to FDA | 2019-04-16 |
| Date Reported to Mfgr | 2019-05-03 |
| Date Added to Maude | 2019-05-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MICROTEK |
| Generic Name | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2019-05-03 |
| Model Number | 1 |
| Catalog Number | 3981 |
| Lot Number | D183304 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK MEDICAL, INC. |
| Manufacturer Address | 13000 DEERFIELD PARKWAY SUITE 300 ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |