MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-01 for 3M? STERI-DRAPE? LARGE OPHTHALMIC DRAPE N/A 1065NS manufactured by 3m Health Care.
[109828821]
Lot number was not provided. Without a lot number, expiration date, manufacturer date and udi could not be determined. No sample has been received to date. This product is subject to sterilization by distributor who is the kit manufacturer. Multiple attempts have been made to obtain additional information for investigation of this reported event.
Patient Sequence No: 1, Text Type: N, H10
[109828822]
A distributor reported a patient experienced an "eye rash" allegedly associated with use of a 1065ns 3m? Steri-drape? Large ophthalmic drape. The patient was treated with tobradex ointment to lower lid and cheek and the rash resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00061 |
| MDR Report Key | 7561112 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-06-01 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-05-17 |
| Date Added to Maude | 2018-06-01 |
| 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 | DIANNE GIBBS |
| Manufacturer Street | 2510 CONWAY AVE 3M CENTER BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M EDUMEX S.A. DE C.V. |
| Manufacturer Street | 6620 ORIENTE, CALLE RAMON RIVERA LARA, CD. |
| Manufacturer City | JUAREZ, CHIHUAHUA 32690 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? STERI-DRAPE? LARGE OPHTHALMIC DRAPE |
| Generic Name | SURGICAL DRAPE |
| Product Code | PUI |
| Date Received | 2018-06-01 |
| Model Number | N/A |
| Catalog Number | 1065NS |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-01 |