MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-07-23 for NEXCARE OPTICLUDE ORTHOPTIC EYE PATCH 1539 manufactured by 3m Consumer Health Care.
[2832872]
Customer reports her (b)(6) daughter has to wear an eye patch daily for 6 hours, under doctor's orders. She has been doing this for about 2 months now, using nexcare opticlude and other brands. She has used 9 opticlude so far. A few days ago, she began noticing her daughter's skin was red after removing the eye patch. Yesterday when she removed it, some skin came off with it and there was a very small amount of bleeding. She's been treating it with an antibiotic ointment.
Patient Sequence No: 1, Text Type: D, B5
[10054938]
Product is labeled: gentle, hypoallergenic adhesive. Latex free materials. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2012-00027 |
| MDR Report Key | 2672057 |
| Report Source | 04 |
| Date Received | 2012-07-23 |
| Date of Report | 2012-06-21 |
| Date of Event | 2012-06-19 |
| Report Date | 2012-06-21 |
| Date Mfgr Received | 2012-06-21 |
| Date Added to Maude | 2012-07-30 |
| 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 | LISA NELSON |
| Manufacturer Street | BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer G1 | 3M CONSUMER HEALTH CARE |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXCARE OPTICLUDE ORTHOPTIC EYE PATCH |
| Generic Name | 886.4750 OPHTHALMIC EYE SHIELD |
| Product Code | HOY |
| Date Received | 2012-07-23 |
| Model Number | 1539 |
| Catalog Number | 1539 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M CONSUMER HEALTH CARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-23 |