MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BIOCLUSIVE 15X20CM STERILE; FILM DRESSING

Model Number BIP1520

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not returned.

Event Description

Aspen surgical received a report from the distributor indicating that a bioclusive pouch was discovered with a seal issue.The item was not in use and no injury/death was reported.This report was filed in our complaint handling system for number (b)(4).

• Brand Name: BIOCLUSIVE 15X20CM 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 ; 6165367508
• MDR Report Key: 8944509
• MDR Text Key: 158966973
• Report Number: 1836161-2019-00065
• 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
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BIP1520
• Device Catalogue Number: BIP1520
• Device Lot Number: 193816
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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