MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2018-03-27 for RA47148N manufactured by Medline Industries Inc..
[103649567]
It was reported that the end-user experienced a skin tear after removing the non-stick pad from a wound. Per the end-user the wound was being treated with an antibiotic ointment. The reported skin tear was experienced where her skin was in contact with the product's adhesive. It is unknown how long the non-stick pad was in use for and how it was removed. According to the end-user her antibiotic treatment was extended for an additional two weeks following the reported incident. The original sample was discarded and was not returned to the manufacturer for evaluation. Due to the need for additional medical intervention and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[103649568]
It was reported that the end-user experienced a skin tear after removing the non-stick pad from a wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00018 |
| MDR Report Key | 7376436 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2018-03-27 |
| Date of Report | 2018-03-27 |
| Date of Event | 2018-02-21 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2018-03-27 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NON-STICK PAD |
| Product Code | NAB |
| Date Received | 2018-03-27 |
| Catalog Number | RA47148N |
| 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 | 2018-03-27 |