MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-18 for WAL47148 manufactured by Medline Industries Inc..
[136486572]
It was reported that the non-stick pads with adhesive tabs were used to cover end user's left shin abrasion. Per report, "within a few hours," the end-user developed "red, small bumpy, blisters" to the area under the pad. It was denied that end-user used or applied any other products (i. E. Ointments, creams, lotions) prior to application of the nonstick pad. Per report, approximately a week later, the end-user went to an urgent care where he was prescribed with medrol dose pack (anti-inflammatory medication). The end-user reportedly did not improve with taking medrol dose pack and he went to his primary physician two weeks later. The end-user was prescribed with another dose of anti-inflammatory medications and then his symptoms reportedly resolved. Per report, this is the first time that end-user used these non-stick pads and he has no known allergies. Due to the reported incident and required medical intervention, this medwatch is being filed. Samples are not available to be returned for evaluation. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[136486573]
It was reported that end-user required anti-inflammatory medications after developing an allergic reaction to the non-stick pads with adhesive tabs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00013 |
| MDR Report Key | 8347538 |
| Date Received | 2019-02-18 |
| Date of Report | 2019-02-18 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2019-01-23 |
| Date Added to Maude | 2019-02-18 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | PAD,NON-STICK,WLMRT,W/ADH,3"X4",ST,10/BX |
| Product Code | NAB |
| Date Received | 2019-02-18 |
| Catalog Number | WAL47148 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-18 |