MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-17 for COLD THERAPY CT-99 manufactured by Cincinnati Sub-zero Products, Llc.
[130628094]
User reported a ct-99 pad leaked on a patient's surgical site. Csz opened complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130628095]
Customer stated a ct-99 pad leaked on a patient's surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1516825-2018-00026 |
| MDR Report Key | 8171386 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-12 |
| Date Mfgr Received | 2018-11-21 |
| Date Added to Maude | 2018-12-17 |
| 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 | MS. CHRISTINA MIRACLE |
| Manufacturer Street | 12011 MOSTELLER ROAD |
| Manufacturer City | CINCINNATI OH 45241 |
| Manufacturer Country | US |
| Manufacturer Postal | 45241 |
| Manufacturer Phone | 5133265295 |
| Manufacturer G1 | CINCINNATI SUB-ZERO PRODUCTS, LLC |
| Manufacturer Street | 12011 MOSTELLER ROAD |
| Manufacturer City | CINCINNATI OH 45241 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45241 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLD THERAPY |
| Generic Name | COLD THERAPY PAD |
| Product Code | ILO |
| Date Received | 2018-12-17 |
| Model Number | CT-99 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CINCINNATI SUB-ZERO PRODUCTS, LLC |
| Manufacturer Address | 12011 MOSTELLER ROAD CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-17 |