MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-07-16 for SITZ BATH 1616700692 IH3650 manufactured by Invacare Cleveland Street.
[6056528]
Door seal leaking.
Patient Sequence No: 1, Text Type: D, B5
[13974294]
(b)(4). Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219590-2015-00111 |
| MDR Report Key | 4918482 |
| Report Source | 08 |
| Date Received | 2015-07-16 |
| Date of Report | 2015-06-22 |
| Date Mfgr Received | 2015-06-22 |
| Date Added to Maude | 2015-07-16 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN GUYTON |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE CLEVELAND STREET |
| Manufacturer Street | 899 CLEVELAND STREET |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SITZ BATH 1616700692 |
| Generic Name | BATH, SITZ, NONPOWERED |
| Product Code | KTC |
| Date Received | 2015-07-16 |
| Model Number | IH3650 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CLEVELAND STREET |
| Manufacturer Address | 899 CLEVELAND STREET ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-16 |