JACKSON-PRATT * SU130-1323

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-06-24 for JACKSON-PRATT * SU130-1323 manufactured by Allegiance Health Care.

Event Text Entries

[16756054] 58 y/o developed infection & required re-admission & surgery for removal of a retained portion of a jackson-pratt drain. Initial abdominal surgery with insertion of drain was done 1999. Drain initially removed in physician's office after pt was discharged. Physician unaware that a portion of the drain had broken off and remained in the pt. Pt developed an abdominal wall infection which prompted the exploration which occurred 4/29/99.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 231356
• MDR Report Key: 231356
• Date Received: 1999-06-24
• Date of Report: 1999-05-13
• Date of Event: 1999-04-29
• Date Facility Aware: 1999-05-03
• Report Date: 1999-05-18
• Date Reported to Mfgr: 1999-05-18
• Date Added to Maude: 1999-07-14
• 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: 3
• Initial Report to FDA: 3
• 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: JACKSON-PRATT
• Generic Name: SILICONE ROUND DRAIN W/RADIOPAQUE STRIPPED
• Product Code: JCY
• Date Received: 1999-06-24
• Model Number: *
• Catalog Number: SU130-1323
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 224254
• Manufacturer: ALLEGIANCE HEALTH CARE
• Manufacturer Address: ONE BAXTER PARKWAY DEERFIELD IL 60015 US
• Baseline Brand Name: DRAIN, SUCTION, 15FR, ROUND
• Baseline Generic Name: WOUND DRAIN
• Baseline Model No: SU130-1323
• Baseline Catalog No: SU130-1323
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-06-24