MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-09 for PERMOBIL? TRU-SHAPE? manufactured by The Comfort Companies, L.l.c..
| Report Number | 2135139-2019-00001 |
| MDR Report Key | 8773364 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-07-09 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-06-11 |
| Date Mfgr Received | 2019-06-11 |
| Device Manufacturer Date | 2019-01-10 |
| Date Added to Maude | 2019-07-09 |
| 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 | MR. DAN WELLS |
| Manufacturer Street | 1930 S. CALHOUN DRIVE |
| Manufacturer City | NEW BERLIN, WI WI 53151 |
| Manufacturer Country | US |
| Manufacturer Postal | 53151 |
| Manufacturer Phone | 2629097131 |
| Manufacturer G1 | THE COMFORT COMPANIES, L.L.C. |
| Manufacturer Street | 1930 S. CALHOUN DRIVE |
| Manufacturer City | NEW BERLIN, WI WI 53151 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53151 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMOBIL? TRU-SHAPE? |
| Generic Name | TRU-SHAPE |
| Product Code | IMP |
| Date Received | 2019-07-09 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE COMFORT COMPANIES, L.L.C. |
| Manufacturer Address | 1930 S. CALHOUN DRIVE NEW BERLIN, WI WI 53151 US 53151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-09 |