MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-12-21 for MSP SCHMEISER PROCEDURE KIT MSPKIT manufactured by Outside Vendor/unk.
[3057971]
Procedure type: according to the reporter: product: (b)(4), katarakt set. One of the users reacted with high allergic on the coat and cover, which are included in this set. Allergic is on the breathing. The user shows swelled mucosa to the point of breathlessness. The user knows about her latex allergy.
Patient Sequence No: 1, Text Type: D, B5
[10368506]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219161-2012-00004 |
| MDR Report Key | 2892188 |
| Report Source | 01,05,06 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-11-26 |
| Date of Event | 2012-11-26 |
| Date Mfgr Received | 2012-11-26 |
| Date Added to Maude | 2013-01-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY, QA |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | OUTSIDE VENDOR/UNK |
| Manufacturer Street | 150 GLOVER AVE. |
| Manufacturer City | NORWALK CT 06856 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06856 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MSP SCHMEISER PROCEDURE KIT |
| Generic Name | NONE |
| Product Code | FHO |
| Date Received | 2012-12-21 |
| Catalog Number | MSPKIT |
| Lot Number | 1216X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OUTSIDE VENDOR/UNK |
| Manufacturer Address | 150 GLOVER AVE. NORWALK CT 06856 US 06856 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-21 |