MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-12 for DEPEND FEMALE S/M manufactured by Kimberly-clark Corporation Cold Springs.
[141821693]
A manufacturer lot code was not provided. With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and supporting records can be performed.
Patient Sequence No: 1, Text Type: N, H10
[141821694]
Consumer's son reported that his mother presented with difficulty breathing and was transported by ambulance to the er. She was diagnosed with a urinary tract infection of the bladder and urethra and was given cephalexin 500 ml. Consumer has improved and the uti has resolved. Consumer's son believed the uti was due to the product not absorbing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184163-2019-00001 |
| MDR Report Key | 8511264 |
| Report Source | CONSUMER |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-12 |
| 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 | CHRIS MAERTZ |
| Manufacturer Street | 2100 WINCHESTER ROAD |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207214907 |
| 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 | 2019-04-12 |
| Model Number | FEMALE S/M |
| 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 | 2019-04-12 |