DILAPAN-S 4X65MM NA

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 2013-04-23 for DILAPAN-S 4X65MM NA manufactured by Medicem Technology S.r.c..

Event Text Entries

[20701459] Dilapan-s broke during extraction.
Patient Sequence No: 1, Text Type: D, B5

[20864602] Complaint forwarded distributor in (b)(4) to manufacturer. Event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3003994796-2013-00001
• MDR Report Key: 3142456
• Report Source: 01,05
• Date Received: 2013-04-23
• Date of Report: 2013-04-15
• Date of Event: 2013-02-08
• Date Mfgr Received: 2013-02-08
• Device Manufacturer Date: 2012-06-01
• Date Added to Maude: 2013-06-12
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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 HYGROSCOPIC CERVICAL DILATOR
• Product Code: LOB
• Date Received: 2013-04-23
• Model Number: 4X65MM
• Catalog Number: NA
• Lot Number: DS270312465
• ID Number: NA
• Device Expiration Date: 2015-06-01
• 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 S.R.C.
• Manufacturer Address: KARLOVARSKA 20 KAMENNE ZEHROVICE 27301 EZ 27301

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2013-04-23