MAUDE Adverse Event Report: ORGANOGENESIS PURAPLY ANTIMICROBIAL WOUND MATRIX

Model Number	1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided suggests that it is possible that the infection may have been related to the application of puraply am, however limited information is available about the event.Infection in wounds can be caused by a multitude of different factors and although enterobacter species can cause skin and soft tissue infections, recent trends distinguish its increasing role in institutionally acquired wound infections and the occurrence of skin and soft tissue infections in previously healthy individuals in the community, occasionally as a result of multiple resistant strains.Previously submitted sep 13, 2017, but failed final acknowledgement, found during file closure activities.
Event or Problem Description
The patient had puraply am applied to a wound (unknown location, unknown etiology) on (b)(6) 2017.At the time of the application, the wound presented with some erythema, but was not infected and bone/tendon was not exposed.The wound was free of debris and necrotic tissue.Puraply am was placed dry and then rehydrated and in contact with the wound bed, covered with mepitel.The patient was told to follow up in one week.On the patients follow up visit on (b)(6) 2017, infection was noted as peri wound erythema, increase in wound size and cultures revealing enterobacter species.Additional information about the wound, the current status of the patient and outcome is unknown.Whether any medical or surgical intervention was required is unknown and whether the product was removed or reapplied is unknown.
Additional Manufacturer Narrative
This supplemental emdr (follow-up report no.001) is to correct information previously submitted in emdr mfr report #1221816-2017-00002.Specifically, the device identifier portion of the unique device identifier (udi) number listed in on the medwatch fda form 3500a was incorrect.The udi number on the initial emdr submission was (b)(4).This emdr provides the correct udi number for the product puraply antimicrobial wound matrix which is (b)(4).For the initial mdr submission the 'event type' in h1 of the fda medwatch form 3500a was listed as 'no information' because it is unclear whether the event that occured resulted in a serious injury (this was unable to be assessed due to a lack of information that was able to be obtained).For this supplemental correction however the option of 'no information' was not able to be selected for 'event type' and therefore 'serious injury' was selected, as it was the most appropriate option available (i.E.No death reported, no malfunction reported).There are no other changes to the information contained in the initial mdr submission #1221816-2017-00002.

• Brand Name: PURAPLY ANTIMICROBIAL WOUND MATRIX
• Common Device Name: PURAPLY ANTIMICROBIAL WOUND MATRIX
• Manufacturer (Section D): ORGANOGENESIS; 150 dan road; canton MA 02021
• MDR Report Key: 7404500
• Report Number: 1221816-2017-00002
• Device Sequence Number: 11315426
• Product Code: FRO
• UDI-Device Identifier: 00618474000039
• UDI-Public: (01)00618474000039(10)AM170417.1.1D(17)2019-02-22
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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 Expiration Date: 02/22/2019
• Device Model Number: 1
• Device Lot Number: AM170417.1.1D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other