MAUDE Adverse Event Report: CALDERA MEDICAL INC. DESARA BLUE; PELVIC MESH

Catalog Number	CAL-DS01B
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Urinary Retention (2119)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the sales rep, the complaint sling was implanted in the patient and is not available for return investigation, therefore the complaint could neither be substantiated nor refuted.As per the product ifu #10-139-03, voiding dysfunction and obstruction due to placing too much tension to the mesh implant are known adverse reactions as indicated in the adverse reactions section of the ifu.To prevent this, surgeons are advised to place the sling in a tension free manner as indicated in the surgical techniques sections of the ifu.The lot history record reveals zero non-conformances associated with desara blue, lot # h09002.The product implanted was not expired at the time of the procedure.No device failure has been identified.
Event or Problem Description
Sales rep reports the following complaint from dr.(b)(6) regarding tensioning issues with desara slings due to a lack of "center tab." surgeon states that the past two patients she implanted with desara had retention issues and could not void for several days post op."dr.(b)(6) at (b)(6) hospital, (b)(6).Boston obtryx user - outside in approach.Dr.(b)(6) has trialed desara blue for 3 cases and desara ss for 2 cases and had a few issues but biggest one being that there is no center tab for her to use for tensioning.She said the past 2 patients she implanted with desara had "retention issues and could not void for several days post op".Again, no center tab or tensioning device is the big hot button with this doctor." per sales rep "here are the slings used in the last two patients by dr.(b)(6) - desara blue, lot # h09002, desara blue ss, lot # j07001." a pms report has been filed to capture the issue of a lack of center tab.The issue of post-op urinary retention is captured in this product complaint and accompanying complaint (b)(4).

• Brand Name: DESARA BLUE
• Common Device Name: PELVIC MESH
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• MDR Report Key: 8724953
• Report Number: 3003990090-2018-01456
• Device Sequence Number: 19314019
• Product Code: OTN
• UDI-Device Identifier: 00890594000650
• UDI-Public: 00890594000650
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K1326069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 09/12/2020
• Device Catalogue Number: CAL-DS01B
• Device Lot Number: H09002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2019
• 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: Hospitalization