MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-09-18 for POISE manufactured by Kimberly-clark Corporation.
[120530423]
Neither product model or manufacturer lot code were provided. With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and records can be performed. 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
[120530424]
A consumer called to report burning sensation/irritation with poise pads. During phone a call she mentioned that her sister-in-law was hospitalized for burning sensation/irritation from using poise pads. After an unknown period of time the consumer's sister-in-law passed away. The cause of death was not provided. It was reported that at the time the sister-in-law was experiencing stomach problems and burning/irritation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003701733-2018-00052 |
| MDR Report Key | 7884810 |
| Report Source | OTHER |
| Date Received | 2018-09-18 |
| Date of Report | 2018-09-18 |
| Date Mfgr Received | 2018-08-20 |
| Date Added to Maude | 2018-09-18 |
| 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 ROAD |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207215889 |
| Manufacturer G1 | KIMBERLY-CLARK CORPORATION |
| Manufacturer Street | 2100 WINCHESTER 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 | POISE |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2018-09-18 |
| 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 |
| Manufacturer Address | 2100 WINCHESTER ROAD NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-09-18 |