UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-20 for UNKNOWN manufactured by Unknown, Unk.

Event Text Entries

[58018380] (b)(6). Date of event not provided by the complainant. Product code pag / pai. Lot number not provided by the complainant. Surgeon name not provided by the complainant. Implant date not provided by the complainant. As requested by the fda, we have made note of the product code. The product code listed is not necessarily the product code assigned to the device 510(k), but rather the product code that seems the most appropriate based on the surgical procedure in which the product was implanted. Based on the information provided by the complainant, details regarding a specific correlation between a cook biotech incorporated manufactured product? S performance and the alleged injury remain unknown. A root cause of the claim allegations is inconclusive due to the lack of details provided by the complainant. All other matters relating to this litigation are being handled by our attorney. A follow-up mdr will be filed if additional details are received.
Patient Sequence No: 1, Text Type: N, H10


[58018381] The patient was reportedly implanted with an unspecified manufacturer's pelvic mesh product(s). The patient and her attorney have alleged that as a result of this/these product(s) being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1835959-2016-00577
MDR Report Key6045132
Report SourceCONSUMER
Date Received2016-10-20
Date of Report2016-10-19
Date Mfgr Received2016-09-30
Date Added to Maude2016-10-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PERRY GUINN
Manufacturer Street1425 INNOVATION PLACE
Manufacturer CityWEST LAFAYETTE IN 47906
Manufacturer CountryUS
Manufacturer Postal47906
Manufacturer Phone7654973355
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Product CodePAG
Date Received2016-10-20
Catalog NumberUNKNOWN
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN, UNK
Manufacturer AddressUNKNOWN UNKNOWN UNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2016-10-20

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