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.
[120530324]
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
[120530325]
A consumer called to report burning sensation/irritation with poise pads. During phone call she mentioned that her friend was in the hospital for burning sensation/rash and bladder infection from wearing poise pad. Neither the friend nor the friend's family have reached out to us to report this. Since we do not have her contact information, there is no way to follow up on progress, verify cause of hospitalization, and if the poise pad product was involved. Consumer stated she would encourage her to call in and report this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003701733-2018-00051 |
| MDR Report Key | 7884807 |
| 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 |