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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TEM1509G
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Foreign Body Reaction (1868); Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Hernia (2240); Ulcer (2274); Respiratory Failure (2484); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Concomitant product: fortiva porcine dermis, 10x25 cm (product id: pd1025, lot number: mp161601). (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a ventral incisional hernia. It was reported that after the implant, the patient experienced recurrence, abscess, cellulitis, bacterial infection, granuloma, ulcer, granulation tissue, inflammation, fibrosis, foreign body reaction, (b)(6), infection, abdominal pain, erythema, skin warmth, purulent material, failure of mesh, disrupted mesh, respiratory failure, and fibrinous reactive tissue. Post-operative patient treatment included revision surgery, hernia repair with new mesh, admission to hospital, antibiotics, lysis of adhesions, removal of hernia sac, reduction of hernia contents, debridement of skin/ subcutaneous tissue/muscle/muscle fascia, abdominal wall component separation, placement of drains, closure of rectus fascia, debridement/ resection of skin/ subcutaneous stitch granuloma, fibrinous reactive tissue dissected, medication, and removal of mesh.

 
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Brand NamePROGRIP
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key11435781
MDR Text Key238356543
Report Number9615742-2021-00521
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 03/08/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTEM1509G
Device Catalogue NumberTEM1509G
Device LOT NumberSSH0968X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/13/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/08/2021 Patient Sequence Number: 1
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