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 2018-05-16 for INTRATEMP THERMABASIN DRAPE ITB100 manufactured by Microtek Medical, Inc..
[108498983]
A picture was provided that showed a crack in the bottom of the basin. No sample has been received for investigation. The investigation for this complaint is pending a response from the supplier. A follow up report will be submitted once additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[108498984]
Here are several pics of the packaging and basins that (b)(6) has had problems with. 1st pic cracked basin, unfortunately no lot # no injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013401749-2018-00003 |
| MDR Report Key | 7519627 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-16 |
| Date of Report | 2018-04-16 |
| Date Mfgr Received | 2018-04-16 |
| Date Added to Maude | 2018-05-16 |
| 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 | 2018-05-16 |
| Model Number | ITB100 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-05-16 |