MAUDE Adverse Event Report: ALLERGAN ALLODERM; CYMETRA MICRONIZED ALLODERM 2CC

Catalog Number 603020

Device Problems Crack (1135); Leak/Splash (1354); Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 10/11/2017

Event Type  malfunction  

Event Description

Upon injection physician noted product leaking out of a crack in the syringe.He was able to inject 1cc of the 2ccs the syringe contained.Staff noted that the physician was hitting the syringe on the table during mixing, but he stated that if that was enough to damage it, it must have already been damaged.Per site reporter: manufacturer did not charge us for the product.

• Brand Name: ALLODERM
• Type of Device: CYMETRA MICRONIZED ALLODERM 2CC
• Manufacturer (Section D): ALLERGAN; 2525 dupont drive; irvine CA 92612
• MDR Report Key: 7053056
• MDR Text Key: 92778706
• Report Number: 7053056
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017,11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 603020
• Device Lot Number: YH100127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1