MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-09-02 for HEMOCCULT? DEVELOPER 62115 manufactured by Beckman Coulter.
[3647879]
An eye doctor informed beckman coulter that a customer had inadvertently used the hemoccult developer as eye drops and was coming in for an emergency appointment. However, the eye doctor reported that the patient had cancelled the appointment and was sent to an urgent care clinic instead. The eye doctor indicated that the patient is a medical staff. No additional information regarding the patient is available since the patient did not come in to see the eye doctor. The condition of the patient is unknown and it is not known of which urgent care clinic the customer went to following the event.
Patient Sequence No: 1, Text Type: D, B5
[11133344]
The hemoccult developer's product instructions state "do not use in eyes" and the kit box has a warning statement of "caution do not use in eyes". The bottle's label artwork also contains an image depicting to not use the developer in the eyes. The hemoccult developer has warnings on every piece of artwork and product instructions that the developer is not to be used in the eyes. It is suspected that the patient did not read the bottle before using the developer as eye drops. Beckman coulter recommends that customers read all product instructions and labeling before using the product. Use error caused or contributed to event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518658-2013-00002 |
| MDR Report Key | 3320960 |
| Report Source | 00,05 |
| Date Received | 2013-09-02 |
| Date of Report | 2013-08-06 |
| Date of Event | 2013-08-06 |
| Date Mfgr Received | 2013-08-06 |
| Date Added to Maude | 2013-09-03 |
| 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 | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 606 ELMWOOD AVE. |
| Manufacturer City | SHARON HILL PA 19079 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19079 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCCULT? DEVELOPER |
| Generic Name | REAGENT, OCCULT BLOOD |
| Product Code | KHE |
| Date Received | 2013-09-02 |
| Model Number | NA |
| Catalog Number | 62115 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-02 |