MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-10-15 for 3M NEXCARE OPITCLUE EYE PATCH 1539 manufactured by 3m Health Care.
[20919042]
Customer used the nexcare opticlude eye patch after being stung by a bee. He is allergic to bees. He went to the emergency room and doctor suggested to use eye patches. The customer applied three patches. First and second patch removed without issue. Before applying the third patch, the customer cleaned the area with a solution the doctor gave him. The customer did not know the name of the cleaning solution. When he went to remove the third patch, it was difficult to remove and it pulled skin off. The skin peeled off underneath the eye almost like a horseshoe shape. Customer has a doctor appointment. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
[21225123]
Method: product was not returned. Results: device performed according to specifications. Conclusions: user-interface caused event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2010-00117 |
| MDR Report Key | 1878352 |
| Report Source | 04 |
| Date Received | 2010-10-15 |
| Date of Report | 2010-09-08 |
| Date of Event | 2010-09-08 |
| Date Mfgr Received | 2010-09-15 |
| Date Added to Maude | 2010-10-26 |
| 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 | 0 |
| Manufacturer Contact | LISA NELSON |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517332334 |
| Manufacturer G1 | 3M HEALTH CARE |
| Manufacturer City | ST. PAUL MN 55144100 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55144 1000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M NEXCARE OPITCLUE EYE PATCH |
| Generic Name | EYE PATCH |
| Product Code | HOY |
| Date Received | 2010-10-15 |
| Model Number | 1539 |
| Catalog Number | 1539 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN 55144100 US 55144 1000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-15 |