MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-02 for PREM UPAD, MAXIMUM, 24X36IN TEAL UPPM2436 manufactured by Beijing Beishute Maternity & Child Articles Co, Ltd.
[3889109]
Reportable stage ii coccyx area increase amount of incontinence dermatitis. Additional treatment was needed for pt. The pads are too thick, not wicking and do not allow proper air flow from the low air loss beds.
Patient Sequence No: 1, Text Type: D, B5
[10937122]
Sample was not received for eval and a lot number was not provided; therefore, a review of the device history record could not be performed. The product is designed to absorb fluid by dispersing fluid across the super absorbent polymer. This allows the product to absorb the liquid fast and has a small re-wet after absorption. Based upon the limited information and lack of samples we are unable to determine the root cause for the issue reported. This appears to be an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006400113-2013-00001 |
| MDR Report Key | 3284119 |
| Report Source | 05,06 |
| Date Received | 2013-08-02 |
| Date of Report | 2013-08-02 |
| Date of Event | 2013-04-24 |
| Date Mfgr Received | 2013-07-10 |
| Date Added to Maude | 2013-10-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHENG QIUJU |
| Manufacturer Street | BEIJING ECONONIC DEVELOPMENT AREA |
| Manufacturer City | BEIJING 101500 |
| Manufacturer Country | CH |
| Manufacturer Postal | 101500 |
| Manufacturer Phone | 089098323 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREM UPAD, MAXIMUM, 24X36IN TEAL |
| Generic Name | BEDDING, DISPOSABLE, MEDICAL |
| Product Code | KME |
| Date Received | 2013-08-02 |
| Model Number | UPPM2436 |
| Catalog Number | UPPM2436 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEIJING BEISHUTE MATERNITY & CHILD ARTICLES CO, LTD |
| Manufacturer Address | BEIJING ECONONIC DEVELOPMENT AREA BEIJING 101500 CH 101500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-08-02 |