INVITRIA OPHTHALMIC SPECULUM MW-200-P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-01 for INVITRIA OPHTHALMIC SPECULUM MW-200-P manufactured by Medical Workshop B.v..

MAUDE Entry Details

• Report Number: MW5087789
• MDR Report Key: 8758038
• Date Received: 2019-07-01
• Date of Report: 2019-06-10
• Date Added to Maude: 2019-07-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: INVITRIA OPHTHALMIC SPECULUM
• Generic Name: SPECULA, OPHTHALMIC
• Product Code: HNC
• Date Received: 2019-07-01
• Catalog Number: MW-200-P
• Lot Number: 09244-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDICAL WORKSHOP B.V.
• Manufacturer Address: GRONINGEN NL

Device Sequence Number: 2

• Brand Name: INVITRIA OPHTHALMIC SPECULUM
• Generic Name: SPECULA, OPHTHALMIC
• Product Code: HNC
• Date Received: 2019-07-01
• Catalog Number: MW-200-P
• Lot Number: 12988-18
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MEDICAL WORKSHOP B.V.
• Manufacturer Address: GRONINGEN NL

Device Sequence Number: 3

• Brand Name: INVITRIA OPHTHALMIC SPECULUM
• Generic Name: SPECULA, OPHTHALMIC
• Product Code: HNC
• Date Received: 2019-07-01
• Catalog Number: MW-200-P
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MEDICAL WORKSHOP B.V.
• Manufacturer Address: GRONINGEN NL

Device Sequence Number: 4

• Brand Name: INVITRIA OPHTHALMIC SPECULUM
• Generic Name: SPECULA, OPHTHALMIC
• Product Code: HNC
• Date Received: 2019-07-01
• Catalog Number: MW-200-P
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: MEDICAL WORKSHOP B.V.
• Manufacturer Address: GRONINGEN NL

Device Sequence Number: 5

• Brand Name: INVITRIA OPHTHALMIC SPECULUM
• Generic Name: SPECULA, OPHTHALMIC
• Product Code: HNC
• Date Received: 2019-07-01
• Catalog Number: MW-200-P
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: MEDICAL WORKSHOP B.V.
• Manufacturer Address: GRONINGEN NL

Device Sequence Number: 6

• Brand Name: INVITRIA OPHTHALMIC SPECULUM
• Generic Name: SPECULA, OPHTHALMIC
• Product Code: HNC
• Date Received: 2019-07-01
• Catalog Number: MW-200-P
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: MEDICAL WORKSHOP B.V.
• Manufacturer Address: GRONINGEN NL

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-07-01