MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for DEPEND SILHOUETTE manufactured by Kimberly Clark Corp..
[144690363]
I used a depend silhouette diaper for the first time in my (b)(6) daughter who is paraplegic. This diaper has a super absorbing band, and it was merchandised as a night adult incontinence diaper. The next morning her genital area was totally swollen and shows an abrasion in the left groin area. A few days later, her skin broke in the abrasion area and required many months of medical treatment due to the fact that it formed an open injury. Product type: otc. Frequency: at bedtime. How was it taken or used? Topical. Dates of use: (b)(6) 2017 - (b)(6) 2017. Reason for use: urinary incontinence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086512 |
| MDR Report Key | 8597126 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-07 |
| Date of Event | 2017-07-31 |
| Date Added to Maude | 2019-05-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEPEND SILHOUETTE |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2019-05-09 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY CLARK CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-09 |