MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-10-26 for HARLECO SULFOSALICYLIC ACID 5% 1506B manufactured by Em Science, Div. Em Industries Inc..
[20135970]
A hospital lab tech was using 5% sulfosalicylic acid in protein testing. The sulfosalicylic acid had been transfered from the original container to a plastic squeeze bottle. When the bottle was set down sharply on the lab bench it spurted into the lab tech's eye. The lab tech did not initially experience any pain, and delayed washing of the eye. Later lab tech experienced pain, went to emergency room and was given first aid treatment and follow-up care. The hospital lab manager indicated that the lab has taken corrective action to prohibit use of this solution in a plastic squeeze bottle in the future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2244894-1996-00001 |
| MDR Report Key | 45577 |
| Report Source | 05,06 |
| Date Received | 1996-10-26 |
| Date of Report | 1996-10-25 |
| Date of Event | 1996-09-23 |
| Date Mfgr Received | 1996-09-27 |
| Date Added to Maude | 1996-11-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARLECO SULFOSALICYLIC ACID 5% |
| Generic Name | LABORATORY REAGENT |
| Product Code | JIQ |
| Date Received | 1996-10-26 |
| Model Number | NA |
| Catalog Number | 1506B |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 46450 |
| Manufacturer | EM SCIENCE, DIV. EM INDUSTRIES INC. |
| Manufacturer Address | 480 S. DEMOCRAT RD GIBBSTOWN NJ 08027 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-10-26 |