MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-29 for STA CLEANER SOLUTION 00973 manufactured by Diagnostica Stago S.a.s..
[118604475]
(b)(4). Stago will provide a follow-up report(s) once relevant information has become available.
Patient Sequence No: 1, Text Type: N, H10
[118604476]
On (b)(6) 2018: stago received a communication from (b)(6), the clinical laboratory educator/safety coordinator at (b)(6). She claims that they "received some sta cleaner solution for the evolution/compact that leaked because the box was crushed during transport" and when her inventory specialist was dumping it down the sink it splashed on him. It "burned his skin and discolored it". (b)(6) also stated that the shipping company took the reagent out of the original box, placed it into an unmarked box and wrapped it with packing tape. According to the person involved, "one of the packages was just a round ball of packing tape with the (b)(6) label taped on. It was not a box when opening. Everything was wet. The bottles were punctured and crushed. " at first, he did not know it was leaking since there was not any paperwork with the item, but realized what it was when he saw the bottles. Two of the 4 boxes shipped were damaged. On 16aug2018: (b)(6) was contacted by stago to obtain more information about the incident. According to her the person involved has a severe allergy to bleach. It should be noted that sta cleaner solution is a highly dilute disinfectant which does not contain bleach. Additionally, stago does not have any indication that gloves or other ppe were utilized. She stated, "he did not go to the er for further treatment, just self-treated a few blisters due to his allergy. Other than that all is ok. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710666-2018-00001 |
| MDR Report Key | 7827161 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-29 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-08-15 |
| Date Facility Aware | 2018-08-15 |
| Report Date | 2018-08-24 |
| Date Reported to Mfgr | 2018-08-24 |
| Date Mfgr Received | 2018-08-17 |
| Device Manufacturer Date | 2018-06-19 |
| Date Added to Maude | 2018-08-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR WALID BEN AMMAR |
| Manufacturer Street | 2 RUE PIERRE FOSSATI |
| Manufacturer City | FRANCONVILLE VAL-DOISE, 95130 |
| Manufacturer Country | FR |
| Manufacturer Postal | 95130 |
| Manufacturer G1 | DIAGNOSTICA STAGO S.A.S. |
| Manufacturer Street | 3 ALLEE THERESA |
| Manufacturer City | ASNIERE SUR SEINE, 92600 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92600 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STA CLEANER SOLUTION |
| Generic Name | STA CLEANER SOLUTION |
| Product Code | PPM |
| Date Received | 2018-08-29 |
| Catalog Number | 00973 |
| Lot Number | 202430 |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO S.A.S. |
| Manufacturer Address | 3 ALLEE THERESA ASNIERES SUR SEINE, 92600 FR 92600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-29 |