MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-25 for NEXCARE (TM) OPTICLUDE (TM) ORTHOPTIC EYE PATCH 1539 manufactured by 3m Consumer Health Care Division.
[15860169]
Patient in the country of (b)(6) had a surgery. Via hospital protocol for the surgery, an eye patch was required. Skin stripping occurred upon removal of the eye patch which resulted in a slight scar around the patient's right eye.
Patient Sequence No: 1, Text Type: D, B5
[15977197]
Manufacturing site of eye patch: 3m (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2013-00009 |
| MDR Report Key | 3021069 |
| Report Source | 05 |
| Date Received | 2013-03-25 |
| Date of Report | 2013-02-20 |
| Date of Event | 2013-01-18 |
| Date Mfgr Received | 2013-02-20 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2013-03-27 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | LISA NELSON |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| 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 (TM) OPTICLUDE (TM) ORTHOPTIC EYE PATCH |
| Generic Name | 886.4750 OPHTHALMIC EYE SHIELD |
| Product Code | HOY |
| Date Received | 2013-03-25 |
| Model Number | 1539 |
| Lot Number | 211608 |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 DIVISION |
| Manufacturer Address | 3M COMPANY ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-25 |