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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH XENFORM SOFT TISSUE REPAIR MATRIX; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
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BOSTON SCIENTIFIC - MARLBOROUGH XENFORM SOFT TISSUE REPAIR MATRIX; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO Back to Search Results
Model Number UNK166
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120)
Event Date 04/24/2015
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during an apical vaginal vault suspension with xenform procedure performed on (b)(6) 2015.The procedure was completed without complications.According to the complainant, on (b)(4) 2013, the patient experienced pain in the suprapubic area and was treated with hydrocodone.The event was reported to be resolving.The patient also had difficulty emptying her bladder and was treated with a foley catheter.The event was reported as not yet resolved.Additional information received on (b)(4) 2015.On (b)(6) 2015, the patient experienced nausea and was treated with phenergan.The event resolved on (b)(6) 2015.On (b)(6) 2015, the patient experienced urinary tract infection and was treated with an unknown antibiotic.The event has not yet resolved.
 
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during an apical vaginal vault suspension with xenform procedure performed on (b)(6) 2015.The procedure was completed without complications.According to the complainant, on (b)(6) 2013, the patient experienced pain in the suprapubic area and was treated with hydrocodone.The event was reported to be resolving.The patient also had difficulty emptying her bladder and was treated with a foley catheter.The event was reported as not yet resolved.
 
Manufacturer Narrative
The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during an apical vaginal vault suspension with xenform procedure performed on (b)(6) 2015.The procedure was completed without complications.According to the complainant, on (b)(6) 2013, the patient experienced pain in the suprapubic area and was treated with hydrocodone.The event was reported to be resolving.The patient also had difficulty emptying her bladder and was treated with a foley catheter.The event was reported as not yet resolved.
 
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during an apical vaginal vault suspension with xenform procedure performed on (b)(6) 2015.The procedure was completed without complications.According to the complainant, on (b)(6) 2013, the patient experienced pain in the suprapubic area and was treated with hydrocodone.The event was reported to be resolving.The patient also had difficulty emptying her bladder and was treated with a foley catheter.The event was reported as not yet resolved.Additional information received on may 26 and 29, 2015 and june 2, 2015.On (b)(6) 2015, the patient experienced nausea and was treated with phenergan.The event resolved on (b)(6) 2015.On (b)(6) 2015, the patient experienced urinary tract infection and was treated with an unknown antibiotic.The event has not yet resolved.Additional information received on may 06, 2016.The events of pelvic pain and difficulty emptying the bladder occurred on (b)(6) 2015 and not (b)(6) 2013.Additional information received on may 12 and 17, 2016.The event of pelvic pain in the suprapubic perineal area resolved on (b)(6) 2015.The patient's birth date is (b)(6) 1950, not (b)(6) 1955.
 
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during an apical vaginal vault suspension with xenform procedure performed on (b)(6) 2015.The procedure was completed without complications.According to the complainant, on (b)(6) 2013, the patient experienced pain in the suprapubic area and was treated with hydrocodone.The event was reported to be resolving.The patient also had difficulty emptying her bladder and was treated with a foley catheter.The event was reported as not yet resolved.Additional information received on may 26 and 29, 2015 and june 2, 2015.On (b)(6) 2015, the patient experienced nausea and was treated with phenergan.The event resolved on (b)(6) 2015.On (b)(6) 2015, the patient experienced urinary tract infection and was treated with an unknown antibiotic.The event has not yet resolved.Additional information received on may 06, 2016.The events of pelvic pain and difficulty emptying the bladder occurred on (b)(6) 2015 and not (b)(6) 2013.Additional information received on may 12 and 17, 2016.The event of pelvic pain in the suprapubic perineal area resolved on (b)(6) 2015.The patient's birth date is (b)(6).Correction july 22, 2016 and additional information.Correction - according to the physician, the (b)(6) 2015 urinary tract infection (uti) was not related to the xenform device or implantation procedure.Additional info - the (b)(6) 2015 uti resolved on (b)(6) 2015.The (b)(6) 2015 event of "difficulty emptying bladder" resolved on (b)(6) 2015.
 
Manufacturer Narrative
Additional patient identifier: (b)(6).
 
Event Description
It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during an apical vaginal vault suspension with xenform procedure performed on (b)(6) 2015.The procedure was completed without complications.According to the complainant, on (b)(6) 2013, the patient experienced pain in the suprapubic area and was treated with hydrocodone.The event was reported to be resolving.The patient also had difficulty emptying her bladder and was treated with a foley catheter.The event was reported as not yet resolved.Additional information received on may 26 and 29, 2015 and june 2, 2015.On (b)(6) 2015, the patient experienced nausea and was treated with phenergan.The event resolved on (b)(6) 2015.On (b)(6) 2015, the patient experienced urinary tract infection and was treated with an unknown antibiotic.The event has not yet resolved.Additional information received on may 06, 2016.The events of pelvic pain and difficulty emptying the bladder occurred on (b)(6) 2015 and not (b)(6) 2013.Additional information received on may 12 and 17, 2016.The event of pelvic pain in the suprapubic perineal area resolved on (b)(6) 2015.The patient¿s birth date is (b)(6), not february (b)(6).Correction july 22, 2016 and additional information: correction - according to the physician, the (b)(6) 2015 urinary tract infection (uti) was not related to the xenform device or implantation procedure.Additional info - the (b)(6) 2015 uti resolved on (b)(6) 2015.The (b)(6) 2015 event of ¿difficulty emptying bladder¿ resolved on (b)(6) 2015.Updated information april 16, 2018: the (b)(6) 2015 event of "difficulty emptying bladder" resolved on (b)(6) 2016.
 
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Brand Name
XENFORM SOFT TISSUE REPAIR MATRIX
Type of Device
MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
MDR Report Key4796656
MDR Text Key5852008
Report Number3005099803-2015-01407
Device Sequence Number1
Product Code PAJ
Combination Product (y/n)N
PMA/PMN Number
K060984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study,Health Professional,Company Representative,company represent
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/30/2015
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 Physician
Device Model NumberUNK166
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/07/2015
Initial Date FDA Received05/26/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
04/13/2018
09/17/2018
Supplement Dates FDA Received06/22/2015
07/28/2015
05/31/2016
07/23/2016
04/24/2018
10/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
Patient Weight75
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