MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-11-01 for UNDERPAD USAP3136ESLP manufactured by Medline Industries, Inc..
[3735830]
The patient developed a pressure ulcer that the facility attributed to the use of the underpad.
Patient Sequence No: 1, Text Type: D, B5
[11215008]
A patient had been admitted to the hospital with a lumbar spine infection. During the hospitalization, she developed a stage i coccyx pressure ulcer on (b)(6) that later progressed to a stage iii on (b)(6). Various types of wound care dressings had been utilized during the course of treatment and the patient had been placed on an air mattress after it progressed to a stage iii. The facility stated they felt the underpad was the cause of the pressure ulcer because they found it crumpled up underneath the patient. They reported that their protocol is to conduct skin assessments every shift. It is not known how often the patient was repositioned while in bed or if they unloaded pressure after identification of the stage i pressure ulcer. The used sample was returned and no abnormalities were identified. We have had no other similar incidents reported to us for this device. We have not confirmed that the device caused the ulcer. However, due to the reported incident and in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2013-00084 |
| MDR Report Key | 3449012 |
| Report Source | 05,06 |
| Date Received | 2013-11-01 |
| Date of Report | 2013-10-30 |
| Date of Event | 2013-10-22 |
| Date Mfgr Received | 2013-10-02 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-11-06 |
| 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 | 3 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNDERPAD |
| Product Code | KME |
| Date Received | 2013-11-01 |
| Catalog Number | USAP3136ESLP |
| Lot Number | 1370347A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-11-01 |