MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE MEETH HAND PACK (HPNSF)104; ORTHOPEDIC TRAY

Model Number SOPOCHPNSG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blister (4537)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Event Description

Customer reported a fracture blister that they think is due to the current webril.The webril we have been receiving in the meeth hand pack has changed and is causing post op fracture blisters to our patients.One patient's blister was managed with local wound care and antibiotic (keflex) was prescribed.

Manufacturer Narrative

Based on the investigation for component number 2059 (padding,cast, webril, 3inx4yd, cotton, ns), from our meeth hand pack catalog number sopochpnsg, there was a change in material used in the manufacturing process of the padding, cast, webril, 3inx4yd, cotton, ns.The change was completed using the appropriate change control processes and validation activities.The new material met all the required technical specifications and is designed to meet the intended use of the product.The device history record review was completed on the reported lot: 23h034162.There were no issues identified for incorrect material, hard lumps, or other visual inspection criteria.The lot passed all the required in-process verification activities based on the aql sample size.Cardinal health will continue to monitor and trend all similar reported product related issues.

• Brand Name: MEETH HAND PACK (HPNSF)104
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 18711198
• MDR Text Key: 335470499
• Report Number: 1423537-2024-00009
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOPOCHPNSG
• Device Catalogue Number: SOPOCHPNSG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 54 KG