MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-03 for COMFORT RECLINE SPACER H/S- XL 8E4230 manufactured by Prism Medical.
| Report Number | 3007802293-2016-00079 |
| MDR Report Key | 6077668 |
| Date Received | 2016-11-03 |
| Date of Report | 2016-11-03 |
| Date of Event | 2016-10-07 |
| Date Facility Aware | 2016-10-07 |
| Date Mfgr Received | 2016-10-07 |
| Device Manufacturer Date | 2015-02-27 |
| Date Added to Maude | 2016-11-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVE KILBURN |
| Manufacturer Street | 10888 METRO COURT |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal | 63043 |
| Manufacturer Phone | 3142198614 |
| Manufacturer G1 | PRISM MEDICAL |
| Manufacturer Street | 10888 METRO COURT |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63043 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMFORT RECLINE SPACER H/S- XL |
| Generic Name | COMFORT RECLINE SLING |
| Product Code | ILE |
| Date Received | 2016-11-03 |
| Returned To Mfg | 2016-10-31 |
| Model Number | 8E4230 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 21 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISM MEDICAL |
| Manufacturer Address | 10888 METRO COURT MARYLAND HEIGHTS MO 63043 US 63043 |