MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-25 for DEPEND UNDERGARMENTS MAXIMUM manufactured by Kimberly-clark Corporation Cold Springs.
[143227344]
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
[143227345]
Consumer's spouse called to report that her husband put on a depend from a new package and the next morning, he developed a rash around his waist and two hours later the rash spread to his groin. He took off depend and took a shower. The rash was itchy with red hives and spread to his entire body. He went to er, his blood pressure was low due to dehydration from diarrhea and possibly from rash. He was given fluids, (b)(6) was given by mouth, methylprednisone (pf) was given as an injection, and he received intravenous fluids consisting of sodium chloride 0. 9% iv at the er and was discharged home six hours later. His symptoms improved but the hives returned two days later. He went to the er again and was admitted to the hospital for one night. He followed up with an allergist. The only allergy found was to brazil nuts. The rash has resolved and he was doing well now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184163-2019-00002 |
| MDR Report Key | 8552750 |
| Report Source | CONSUMER |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-04-25 |
| 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 | 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 UNDERGARMENTS |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2019-04-25 |
| Model Number | MAXIMUM |
| 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; 2. Other | 2019-04-25 |