MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-07-09 for DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ FIT-FLEX INCONTINENCE UNDERWEAR FOR WOMEN, MAXIMUM manufactured by Neenah Cold Spring Facility.
| Report Number | 2184163-2019-00004 |
| MDR Report Key | 8773139 |
| Report Source | CONSUMER |
| Date Received | 2019-07-09 |
| Date of Report | 2019-07-09 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2019-06-12 |
| 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. CHRIS MAERTZ |
| Manufacturer Street | 2100 WINCHESTER RD |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207214907 |
| Manufacturer G1 | NEENAH COLD SPRING FACILITY |
| Manufacturer Street | 1050 COLD SPRING ROAD |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54956 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2019-07-09 |
| Model Number | FIT-FLEX INCONTINENCE UNDERWEAR FOR WOMEN, MAXIMUM |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEENAH COLD SPRING FACILITY |
| Manufacturer Address | 1050 COLD SPRING ROAD NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-09 |