DISPOSABLE SURGICAL LAP SPONGES UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-02 for DISPOSABLE SURGICAL LAP SPONGES UNKNOWN manufactured by Medline.

Event Text Entries

[20241589] On september 23, 1992 an abdominal surgical procedure was performed. At the completion of the procedure, all sponge counts were verified as being correct by experienced surgical nurses, having a total of 63 year o. R. Experience. On october 5, a c. T. Scan of the patient's abdomen identified a retained lap sponge with an abcess around the sponge. The patient was taken to surgery an the sponge removed. Subsequently, the patient experienced additional complications anad expired on october 8, 1992device labeled for single use. 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. Invalid data - whether 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: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1619
• MDR Report Key: 1619
• Date Received: 1992-11-02
• Date of Report: 1992-10-15
• Date of Event: 1992-09-23
• Date Facility Aware: 1992-10-05
• Report Date: 1992-10-15
• Date Reported to FDA: 1992-10-15
• Date Reported to Mfgr: 1992-10-15
• Date Added to Maude: 1992-11-05
• 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: DISPOSABLE SURGICAL LAP SPONGES
• Generic Name: SURGICAL LAP SPONGES
• Product Code: GER
• Date Received: 1992-11-02
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1542
• Manufacturer: MEDLINE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-11-02