MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-25 for DEPEND UNDERGARMENTS : GARMENT, PROTECTIVE, FOR INCONTINENCE : EYQ FIT FLEX UNDERWEAR FOR WOMEN, LARGE, MAXIMUM ABSOR manufactured by Neenah Cold Spring Facility.
[185960516]
Review of the device history record (dhr), supporting quality records, and two companion samples confirmed no anomalies that may have caused or contributed to the adverse event.
Patient Sequence No: 1, Text Type: N, H10
[185960517]
Consumer reported a half hour into wearing a depend fit flex underwear for women she began to experience a reaction with discomfort, redness, swelling, vaginal odor and pain. She alleged her arms, wrists, hands and vagina were swollen and itchy. She went to the hospital via ambulance. During transport she was given iv benadryl by ems. In the emergency room (er) she was diagnosed with acute contact dermatitis and given ceftriaxone iv and also prednisone and famotidine. She was hospitalized for observation for two nights and discharged home with tapering daily oral steroids and daily famotidine. Consumer reported she was feeling much better and had recovered from her reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184163-2020-00001 |
| MDR Report Key | 9877588 |
| Report Source | CONSUMER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-09-16 |
| Date Added to Maude | 2020-03-25 |
| 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 | MRS. EMILY ARNOULD, RN BSN |
| Manufacturer Street | 2100 WINCHESTER RD |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207213128 |
| 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 | 2020-03-25 |
| Returned To Mfg | 2020-03-05 |
| Model Number | FIT FLEX UNDERWEAR FOR WOMEN, LARGE, MAXIMUM ABSOR |
| Lot Number | LF925918X2222 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Hospitalization; 2. Other | 2020-03-25 |