MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE; CLIP, REMOVABLE (SKIN)

Catalog Number	3013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the device, 3013, reflex tl, skin stapler with tissue lift, 35 wide was being used on approximately on (b)(6) 2022 and the ¿staples do not come out properly, so the adhesion of the skin does not hold." the procedure was not completed and ¿would healing disrupted¿.After further assessment it was discovered that the customer confirmed it was just the wrong size of staple as they are used to.It was actually down to the way they used the article.Nothing of complaint in terms of the article.No other information was received, so it is unknown if the patient received treatment or the patient's current condition.This report is being raised on the basis of injury due to wound healing disrupted.
Additional Manufacturer Narrative
Additional fda product code: qqs.Manufacturer narrative: the device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.In addition, the information from the customer indicated the device was misused.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following: the reflex® one and reflex® tl skin staplers should be used only by personnel with adequate training and knowledge of skin closure procedures.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 3013, reflex tl, skin stapler with tissue lift, 35 wide was being used on approximately (b)(6) 2022 and the ¿staples do not come out properly, so the adhesion of the skin does not hold.¿.The procedure was not completed and ¿would healing disrupted¿.After further assessment it was discovered that the customer confirmed it was just the wrong size of staple as they are used to.It was actually down to the way they used the article.Nothing of complaint in terms of the article.No other information was received, so it is unknown if the patient received treatment or the patient's current condition.This report is being raised on the basis of injury due to wound healing disrupted.

• Brand Name: REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE
• Common Device Name: CLIP, REMOVABLE (SKIN)
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 15672466
• Report Number: 3007305485-2022-00164
• Device Sequence Number: 12342447
• Product Code: FZQ
• UDI-Device Identifier: 10653405050605
• UDI-Public: (01)10653405050605(17)270530(30)6(10)202205314
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3013
• Device Lot Number: 202205314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic