VHA + PLUS LAPAROTOMY SPONGES N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-09 for VHA + PLUS LAPAROTOMY SPONGES N/A manufactured by Medical Action.

Event Text Entries

[20892696] Received notidication via vha urgent recall notice dated 9/8/93 on 9/14/93 regarding recall of laparotomy sponges lot #'s 100 - 1434. Products pulled on 9/14/94. 9/17/93 notified mfg. Representative that sterile products unavailable. Plan established to maintain service. Ordered sterile stock from other companies. Used pre-packaged sterile supplies. Report to surgery chief and infection control function. Source of problem: sterilization of product. Invalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, device recalled by manufacturer/distributor, device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7500
• MDR Report Key: 7500
• Date Received: 1994-01-09
• Date of Report: 1993-09-21
• Date of Event: 1993-09-08
• Date Facility Aware: 1993-09-16
• Report Date: 1993-09-21
• Date Reported to Mfgr: 1993-09-16
• Date Added to Maude: 1994-04-26
• Event Key: 0
• Report Source Code: User Facility 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: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VHA + PLUS LAPAROTOMY SPONGES
• Generic Name: LAPAROTOMY SPONGES
• Product Code: FGS
• Date Received: 1994-01-09
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: 100 - 1434
• ID Number: N/A
• Device Availability: N
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 7179
• Manufacturer: MEDICAL ACTION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-01-09