MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-05 for INTRATEMP THERMABASIN DRAPE ITB100 manufactured by Microtek Medical, Inc..
[110195427]
One sample was received 5/18/18 in (b)(6). The sample was opened, red bagged and contaminated. Photos were taken to show the crack in the bottom of the basin. The sample is being discarded appropriately and will not be sent to (b)(6). A scar was issued to the supplier for this complaint. The investigation is pending a response from the supplier.
Patient Sequence No: 1, Text Type: N, H10
[110195428]
End user reported basin has a crack in it. Medwatch form mw5077290 was received on 5/30/18 with the following information: ecolab intratemp warming unit used during surgery to repair an abdominal aortic aneurysm. Upon tear down of sterile field, it was noted that basin had a small crack in the underneath of basin. Crack was unable to be visualized from sterile portion. The physician was notified, infectious disease was consulted, baseline blood cultures were obtained and patient was placed on further antibiotic therapy for 2 weeks. The patient was stable without fever and was closely monitored. Blood cultures had no growth after 4 days. Pharmacy was dosing vancomycin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013401749-2018-00004 |
| MDR Report Key | 7571298 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-05 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-05-10 |
| Date Mfgr Received | 2018-05-11 |
| Date Added to Maude | 2018-06-05 |
| 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 | 1 ECOLAB PLACE |
| Manufacturer City | ST. PAUL MN 55102 |
| Manufacturer Country | US |
| Manufacturer Postal | 55102 |
| Manufacturer Phone | 6512502237 |
| Manufacturer G1 | MICROTEK MEDICAL, INC. |
| Manufacturer Street | 13000 DEERFIELD PARKWAY SUITE 300 |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRATEMP THERMABASIN DRAPE |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2018-06-05 |
| Returned To Mfg | 2018-05-18 |
| Model Number | ITB100 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-06-05 |