MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-29 for GOODNITES GIRL, S-M manufactured by Kimberly-clark Corporation Paris Plant.
[125329523]
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
[125329524]
This is a non-us event. This occurred in (b)(6). The consumer stated that her daughter developed a rash with two abscesses that needed to be drained and resulted in hospitalization. One abscess was drained, the second became infected and had to be surgically removed. Consumer reported that her child is improving and that the abscess is closing up. Two different packages of the product were used. The other package is reported under 1650783-2018-00002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1650783-2018-00001 |
| MDR Report Key | 8015199 |
| Report Source | CONSUMER |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-10-01 |
| Device Manufacturer Date | 2018-01-07 |
| Date Added to Maude | 2018-10-29 |
| 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 PARIS PLANT |
| Manufacturer Street | 2466 FARM ROAD 137 |
| Manufacturer City | PARIS TX 75460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOODNITES |
| Generic Name | GARMENT, PROTECTIVE, FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2018-10-29 |
| Model Number | GIRL, S-M |
| Lot Number | PA800715X1611 |
| 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 PARIS PLANT |
| Manufacturer Address | 2466 FARM ROAD 137 PARIS TX 75460 US 75460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-10-29 |