*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-01 for * manufactured by Medgyn.

Event Text Entries

[201893] Pt had termination of pregnancy at another medical site. Laminaria were placed preoperatively. Immediately before the procedure, pt's temperature was 101 f. After the procedure, temperature was 104. 7 f. Pt was transferred to hosp where pt had a coagulopathy. Pt had cervical cultures which showed gram negative rods and blood cultures grew e. Coli. Pt responded to intravenous antibiotics and was discharged after 8 days.
Patient Sequence No: 1, Text Type: D, B5

[22081886] Add'l info rec'd from mfr 3/23/01: no investigation of the actual device inserted in the pt and alleged to have caused the infection was possible because the device was disposed of and not returned to the mfr. Furthermore, even if the single use device were still available after use, testing it would be meaningless for the reasons in paragraph (2) below. The mfr's investigation included a review of the records from the eto processing of all lots included in the mdr report. All cycles were run within validated parameters, and no deviations occurred. Importantly, the device in question is not labeled sterile and sterility is not claimed for the device. Mfr has attached correspondence from fda dated 7/26/96, discussing sterility claims for laminaria tents.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021036
• MDR Report Key: 315539
• Date Received: 2001-02-01
• Date of Event: 2000-08-30
• Date Added to Maude: 2001-02-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: *
• Generic Name: LAMINARIA
• Product Code: HDY
• Date Received: 2001-02-01
• Model Number: *
• Catalog Number: *
• Lot Number: 042101
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 305125
• Manufacturer: MEDGYN
• Manufacturer Address: EISENHOWER LANE LOMBARD IL 60418 US

Device Sequence Number: 2

• Brand Name: *
• Generic Name: LAMINARIA
• Product Code: HDY
• Date Received: 2001-02-01
• Model Number: *
• Catalog Number: *
• Lot Number: 61891
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 305126
• Manufacturer: MEDGYN
• Manufacturer Address: EISENHOWER LANE LOMBARD IL 60418 US

Device Sequence Number: 3

• Brand Name: *
• Generic Name: LAMINARIA
• Product Code: HDY
• Date Received: 2001-02-01
• Model Number: *
• Catalog Number: *
• Lot Number: 020901
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 305127
• Manufacturer: MEDGYN
• Manufacturer Address: EISENHOWER LANE LOMBARD IL 60418 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-02-01