MAUDE Adverse Event Report: WPT CORPORATION CAST PADDING; PROSTETHIC AND ORTHOTIC ACCESSORY

Model Number	30-321
Medical Device Problem Codes	Failure to Obtain Sample (2533); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Rash (2033); Skin Disorders (4543); Skin Inflammation/ Irritation (4545)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore we were not able to complete a thorough investigation.A supplier corrective action request (scar) has been sent to vendor in relation to the product issue; however, still waiting for completion.The investigation is incomplete at this time, a follow-up report will be submitted with additional information once received, this report will be updated.
Event or Problem Description
Patient had a post operation skin reaction.
Additional Manufacturer Narrative
Follow-up 2: in follow-up report #1 in section g4 "premarket identification" it displayed the device as a "combination product", the device is not a combination product.
Additional Manufacturer Narrative
A scar was completed by the supplier; however, no root cause was established due to device not being returned for supplier evaluation.Per the supplier (bsn), "no product was reworked and has confirmed that no manufacturing process change has occurred in the past two years.Action will be initiated of pending any negative trends or if additional information is provided by monitoring this product and issue." deroyal has sold a total of (b)(4) units of finished goods of 30-321 since (b)(6) 2019 to present with 19 complaints during this time frame.There has been no other similar complaint using the same reason code or part number in the reported time frame.The investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: CAST PADDING
• Common Device Name: PROSTETHIC AND ORTHOTIC ACCESSORY
• Manufacturer (Section D): WPT CORPORATION; 850 south main street; p.o. box 477; beaver dam KY 42320
• MDR Report Key: 11821197
• Report Number: 1060680-2021-00003
• Device Sequence Number: 17248493
• Product Code: ITG
• UDI-Device Identifier: 50749756024384
• UDI-Public: 50749756024384
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: 30-321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021; 04/26/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/22/2021; 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1