MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-18 for SITZ BATH 1616700692 IH1900IH3652GW manufactured by Invacare Taylor Street.
[26416538]
A return was issued and the product is awaiting receipt and/or evaluation.? A follow up will be filed if/when any additional information is provided.
Patient Sequence No: 1, Text Type: N, H10
[26416539]
Tub was leaking at the bottom of the door.
Patient Sequence No: 1, Text Type: D, B5
[26884704]
Product was returned for evaluation. The return fields in oracle state: plumbing unable to test. No test fixture. Complaint was not confirmed. The underlying cause could not be determined after reviewing the documentation in this investigation.
Patient Sequence No: 1, Text Type: N, H10
[26884785]
Product was returned for evaluation. The return fields in oracle state: plumbing unable to test. No test fixture. Tub was leaking at the bottom of the door.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2015-04579 |
| MDR Report Key | 5087211 |
| Date Received | 2015-09-18 |
| Date of Report | 2015-09-21 |
| Date Mfgr Received | 2015-09-21 |
| Date Added to Maude | 2015-09-18 |
| 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 TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR 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 | ILM |
| Date Received | 2015-09-18 |
| Returned To Mfg | 2015-09-21 |
| Model Number | IH1900IH3652GW |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR STREET |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-18 |