MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for RITEAID SHEER ADHESIVE PADS 2 X 3.75" (5.1 X 9.5CM) RA398569R manufactured by Unknown.
[137169802]
A biopsy of skin neoplasm on lower left leg on (b)(6) 2019. Bandage caused rather severe erythema from the adhesive parts of the pads which persists after removing the bandage ((b)(6)] sheer adhesive pads 2x3. 75? Item #398569. I have photographs of the injury as of 8. 15 am (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084143 |
| MDR Report Key | 8343990 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-15 |
| Date Added to Maude | 2019-02-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RITEAID SHEER ADHESIVE PADS 2 X 3.75" (5.1 X 9.5CM) |
| Generic Name | BANDAGE, ELASTIC, BANDAIDS ADHESIVE |
| Product Code | FQM |
| Date Received | 2019-02-14 |
| Catalog Number | RA398569R |
| Lot Number | 17114 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-14 |