MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-06-29 for MICROTEK PROBE COVER GPC415 manufactured by Microtek Dominicana, S.a..
[1561136]
During a procedure, the probe penetrated the probe cover and contaminated the surgical site. The end user had to flush the incision with antibiotics and treat the patient with antibiotics postoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2010-00003 |
| MDR Report Key | 1756909 |
| Report Source | 06 |
| Date Received | 2010-06-29 |
| Date of Report | 2010-06-29 |
| Date of Event | 2010-06-15 |
| Date Mfgr Received | 2010-06-18 |
| Device Manufacturer Date | 2009-11-13 |
| Date Added to Maude | 2011-02-18 |
| 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 Street | 602 LEHMBERG ROAD |
| Manufacturer City | COLUMBUS MS 39702 |
| Manufacturer Country | US |
| Manufacturer Postal | 39702 |
| Manufacturer Phone | 8888440988 |
| Manufacturer G1 | MICROTEK DOMINICANA, S.A. |
| Manufacturer Street | ZONA FRANCA INDUSTRIAL #2 |
| Manufacturer City | LAROMANA |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROTEK PROBE COVER |
| Generic Name | CORDLESS GAMMA PROBE COVER |
| Product Code | MMP |
| Date Received | 2010-06-29 |
| Model Number | GPC415 |
| Catalog Number | GPC415 |
| Lot Number | D93171 |
| Device Expiration Date | 2014-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK DOMINICANA, S.A. |
| Manufacturer Address | LA ROMANA DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-29 |