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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. POSTERIOR PELVIC FLOOR REPAIR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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ETHICON INC. POSTERIOR PELVIC FLOOR REPAIR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number PFRP01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2009 and mesh was implanted.It was reported that the patient experienced an unknown event.No additional information was provided.
 
Manufacturer Narrative
Date sent to the fda: 05/27/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
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Brand Name
POSTERIOR PELVIC FLOOR REPAIR
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key11654205
MDR Text Key245996376
Report Number2210968-2021-03287
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K013718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 04/08/2021
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 Health Professional
Device Expiration Date10/31/2011
Device Catalogue NumberPFRP01
Device Lot Number3222422
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/26/2021
Initial Date FDA Received04/12/2021
Supplement Dates Manufacturer Received05/26/2021
Supplement Dates FDA Received05/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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