MAUDE Adverse Event Report: COMBE INC ASTROGLIDE; ASTROGLIDE LIQUID PERSONAL LUBRICANT

Model Number ASTROGLIDE LIQUID 5OZ

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685)

Event Date 10/18/2023

Event Type  malfunction  

Event Description

User statement: "used the astroglide as a personal lubricant and ended up with red surface burned skin with some spots down an extra layer or two of skin compared to other spots.Some burning internally.".

Manufacturer Narrative

Report number: mw5147661.Manufacturer: biofilm inc.A subsidiary of combe inc.Date of event: october 18,2023.Date reported: october 18, 2023.Device information: lubricant, patient, vaginal, latex compatible (nuc).Product brand: astroglide liquid.Device type: lubricant, patient.Lot number: a016310.Expiration date: january 12, 2026.Event description: used the astroglide as a personal lubricant and ended up with red surface burned skin with some spots down an extra layer or two of skin compared to other spots.Some burning internally.Is the product otc? yes.How was it taken: topical.Date person first took: n/a.Date person stop use: n/a.Reason for use: n/a.Concomitant medical: n/a.# of complaints for lot filed with biofilm: 0.Background: on december 12,2023 the us fda sent a letter to biofilm, inc.For a burning complaint that was filed with the us fda medwatch program.The letter states that if after a review of the event that a medical device report is required that we submit an mdr in accordance with 21 cfr 803.This memo addresses the december 12, 2023, letter.Lot number: a016310.Lot yield: 144,048 units.Complaint record: 1 (mw5147661).Complaint rate: (b)(4).Investigation: biofilm inc, when receiving this mdr from the medwatch program, opened a complaint file based on the fdr medwatch letter mw5147661.The user was contacted to provide more information but was unable to send us back the medical device for testing.The product in question is astroglide liquid (class 1, 510k k935299).Mfr report #0002025771-2024-07005.Customer product was not returned; therefore, testing was conducted on two retain samples.During batch record review, there was no non-conforming material reports related to the performance of the product.Viscosity for all bulk lots of astroglide liquid used were within specification at 74, 76, 74 cp and ph = 4.6, 4.7, and 4.5 respectively.All micro results passed at the time of testing.On (b)(6) 2024, two retain samples of astroglide liquid were tested to see if the complaint for burning could be confirmed.The user sample was not yet returned, so these results are based on the retain samples that are kept after each job completion.According to quality inspection record (b)(4), revision b, the ph should fall between 3.5 and 5.5, and the micro results should be as follows: <100 cfu/ml tac, <10 cfu/ml yeast and mold, and c.Albicans, p.Aeruginosa, and s.Aureus should all be absent.The results for batch bulk solution 01123.1 are as follows: ph is 4.6, osmo is 1379 mosm/kg, and micro is <100 cfu/ml tac, <10 cfu/ml yeast and mold, and c.Albicans, p.Aeruginosa, and s.Aureus are all absent.The results for batch 01123.1 are as follows: ph is 4.4, osmo is 1391 mosm/kg, and micro is <100 cfu/ml tac, <10 cfu/ml yeast and mold, and c.Albicans, p.Aeruginosa, and s.Aureus are all absent.Lot a016310 osmolality testing.

• Brand Name: ASTROGLIDE
• Type of Device: ASTROGLIDE LIQUID PERSONAL LUBRICANT
• Manufacturer (Section D): COMBE INC; 3225 executive ridge; vista CA 92081
• Manufacturer (Section G): COMBE INC; 3225 executive ridge; vista CA 92081
• Manufacturer Contact: kevin jamil ; 3225 executive ridge; vista 92081 ; 7607279030
• MDR Report Key: 18522699
• MDR Text Key: 332973081
• Report Number: 0002025771-2024-07005
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: ASTROGLIDE LIQUID 5OZ
• Device Lot Number: A016310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White