MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-08-06 for DEPEND FIT FLEX MAX WOMEN S/M manufactured by Kimberly-clark Corporation Cold Springs.
[116060225]
The device history record (dhr) and quality records were reviewed. These documents demonstrate that procedures were correctly followed. Complaints which are serious in nature are reviewed on a regular basis or for due cause to provide visibility and escalation. In addition, complaints are also monitored for trending on a monthly cadence. No further information is available at this time.
Patient Sequence No: 1, Text Type: N, H10
[116060226]
Consumer's wife reported that in (b)(6) 2017 her husband experienced a bladder uti that required hospitalization for a week and a half. He was using either depend fit flex male or women product. Consumer's wife reported that the incontinence product was re-used on her husband. This report is for the fit flex max women. Mdr 2184163-2018-00003 has been submitted for the fit flex male product. He was prescribed antibiotics. His uti was resolved. Consumer's wife reported she was satisfied, no further follow ups are tasked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184163-2018-00002 |
| MDR Report Key | 7751590 |
| Report Source | OTHER |
| Date Received | 2018-08-06 |
| Date of Report | 2018-08-06 |
| Date of Event | 2017-09-01 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2017-05-22 |
| Date Added to Maude | 2018-08-06 |
| 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 | DR. MARIAN VARGAS |
| Manufacturer Street | 2100 WINCHESTER RD |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207215889 |
| Manufacturer G1 | KIMBERLY-CLARK CORPORATION COLD SPRINGS |
| Manufacturer Street | 1050 COLD SPRING RD. |
| 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 |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2018-08-06 |
| Model Number | FIT FLEX MAX WOMEN S/M |
| Lot Number | LF714214X1244 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK CORPORATION COLD SPRINGS |
| Manufacturer Address | 1050 COLD SPRING RD. NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-06 |