MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BIOCLUSIVE 6X7CM STERILE; FILM DRESSING

Model Number BIP0607

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned, picture provided.

Event Description

Customer rejected 101 pouches due to product being stuck in the seal.

Event Description

Customer rejected 101 pouches due to product being stuck in the seal.

• Brand Name: BIOCLUSIVE 6X7CM STERILE
• Type of Device: FILM DRESSING
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 7022734
• MDR Text Key: 92905921
• Report Number: 1836161-2017-00118
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BIP0607
• Device Lot Number: 128239
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1