MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COLLAMEND FM; SURGICAL MESH

Catalog Number	1175112
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Impaired Healing (2378); Prolapse (2475); Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any, the collamend fm may have caused or contributed to the events as alleged.At this time no conclusion can be made.A manufacturing review was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of 67 units released for distribution in february, 2014.Should additional information be obtained, this report will be updated.Note: remains implanted.
Event or Problem Description
The following was reported via (b)(6): the patient was implanted with collamend fm in a procedure performed on (b)(6) 2014.The contact alleges, "the device is too tight my bowel has knitted into the device and as a result my bowel is incapable of functioning"."started with a rectocele, was left with a hole in the bowel post surgery, as surgery was open surgery had contents leaking from my bowel into abdomen, was left with a gapping, growing large open cavity in my abdomen, my navel rotted away it took 15 months to close, district nurses for 9 months and 4 months of a negative energy wound therapy box sucking 300 ml of puss from my abdomen as a result of the failure of the device, i now have another rectocele, an intussusception, an enterocele, and a very large abdominal hernia, and have been told it can't be removed, my only option is an ilostomy.".

• Brand Name: COLLAMEND FM
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8110955
• Report Number: 1213643-2018-04217
• Device Sequence Number: 1693341
• Product Code: FTM
• UDI-Device Identifier: 00801741010569
• UDI-Public: (01)00801741010569
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

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: 07/28/2015
• Device Catalogue Number: 1175112
• Device Lot Number: DAYB0006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/28/2018
• 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: Life Threatening; Required Intervention; Disability