MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-03 for DRAPE ARMOUR RBFPS101L manufactured by Microtek Dominicana, S.a..
[66820378]
The dhr was reviewed for lot d160121. This lot had (b)(4) pcs and was manufactured on 01/14/2016 in combined shift. No defects related to the non conformance were observed during the quality inspection. Based on the review of the device history record, the non conformity doesn't appear to be the result of a personnel, process, or materials issue. No sample was received for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[66820379]
Customer stated that during a procedure the drape was saturated with blood and they were running a line back and forth over the pad in and out of the femoral access and the covering to the pad disintegrated. This was considered compromising to patient safety. No patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2017-00003 |
| MDR Report Key | 6301447 |
| Date Received | 2017-02-03 |
| Date of Report | 2017-01-06 |
| Date Mfgr Received | 2017-01-06 |
| Date Added to Maude | 2017-02-03 |
| 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 | MRS JENNIFER MRKVICKA |
| Manufacturer Street | 370 WABASHA STREET NORTH |
| Manufacturer City | ST. PAUL MN 55102 |
| Manufacturer Country | US |
| Manufacturer Postal | 55102 |
| Manufacturer Phone | 6512502237 |
| Manufacturer G1 | MICROTEK DOMINICANA |
| Manufacturer Street | ZONA FRANCA NO. 2 |
| Manufacturer City | LA ROMANA, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DRAPE ARMOUR |
| Generic Name | RADIATION PROTECTION |
| Product Code | KPY |
| Date Received | 2017-02-03 |
| Model Number | RBFPS101L |
| Lot Number | D160121 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK DOMINICANA, S.A. |
| Manufacturer Address | ZONA FRANCA NO. 2 LA ROMANA, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-03 |