DILAPAN-S 4X55

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-05-06 for DILAPAN-S 4X55 manufactured by Medicem Technology.

Event Text Entries

[15802861] Device was used after its labeled expiration date. Broken piece was removed without complications.
Patient Sequence No: 1, Text Type: N, H10

[15936496] Dilapan-s were used after expiration (may 2010). During extraction one of them broke leaving a piece in uterus. Broken piece was removed subsequently.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003994796-2013-00002
• MDR Report Key: 3136322
• Report Source: 01,05
• Date Received: 2013-05-06
• Date of Report: 2013-04-30
• Date of Event: 2013-04-09
• Date Mfgr Received: 2013-04-16
• Device Manufacturer Date: 2007-04-01
• Date Added to Maude: 2013-06-03
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: KARLOVARSKA TRIDA 20
• Manufacturer City: KAMENNE ZEHROVICE 273 01
• Manufacturer Country: EZ
• Manufacturer Postal: 273 01
• Manufacturer Phone: 317070370
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DILAPAN-S
• Generic Name: DILAPAN-S
• Product Code: LOB
• Date Received: 2013-05-06
• Model Number: 4X55
• Lot Number: DS030407455
• Device Expiration Date: 2010-05-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDICEM TECHNOLOGY
• Manufacturer Address: KAMENNE ZEHROVICE EZ

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2013-05-06