MAUDE Adverse Event Report: SOFRADIM PRODUCTION UNK PARIETEX PRODUCT; NONE

Catalog Number UNK PARIETEX

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 06/21/2007

Event Type  Injury  

Event Description

According to the reporter: the patient alleged injury.Medical history: complete uterine procidentia, large cystorectocele.The cervix is about 10cm down below the introitus.Cystocele and anterior central defect, rectocele.

Manufacturer Narrative

(b)(4).Covidien is submitting this report on behalf of (b)(4), (importer).

• Brand Name: UNK PARIETEX PRODUCT
• Type of Device: NONE
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-01 600; FR F-01600
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux F-01 600; FR F-01600
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3788302
• MDR Text Key: 15107832
• Report Number: 9615742-2014-00140
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK PARIETEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2014
• Initial Date FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR