MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-01-12 for SITZ BATH 1616700692 IH3600XL manufactured by Invacare Cleveland Street.
[35662410]
Should additional information become available a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[35662411]
Customer needs a replacement door seal sent out under the lifetime warranty. Seal is coming apart from the door and the door will not close tightly enough to fill with water.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219590-2016-00003 |
| MDR Report Key | 5359648 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-01-12 |
| Date of Report | 2015-12-23 |
| Date Mfgr Received | 2015-12-23 |
| Date Added to Maude | 2016-01-12 |
| 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 | 3 |
| Event Location | 3 |
| 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 |
| Remedial Action | RL |
| 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 | 2016-01-12 |
| Model Number | IH3600XL |
| 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 | 2016-01-12 |