MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRANSWARMER

Model Number 20421

Device Problem Nonstandard Device (1420)

Patient Problem Burn, Thermal (2530)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.Ref: (b)(4).

Event Description

Recall affected customer reported an adverse - patient was burned.Ref: (b)(4).

Manufacturer Narrative

Ref (b)(4).Investigation: x-initiated manufacturer's investigation, x-no sample returned.Analysis and findings: distribution history the complaint product was purchased from pristech.Manufacturing record review manufacturing record is not applicable to this complaint.Incoming inspection review a review of the incoming inspection record could not be performed because the complaint product lot number was not provided.Should the complaint product lot number be provided going forward, the incoming inspection report will be reviewed, and this complaint amended accordingly.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history showed similar reported complaint condition of infant being burnt.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause while no definitive root cause could be reliably determined, the potential cause may be attributed to restricted/contraindicated device combinations.Correction and/or corrective action corrective action: this issue has been addressed by ecn-22409 document number 20421 rev.G for ifu updates to include additional guidance to restricted/contraindicated device combinations.Coopersurgical will continue to monitor this complaint condition for any trends.(reference capa (b)(4)).

Event Description

Recall affected customer reported an adverse - patient was burned.Ref (b)(4).

• Brand Name: TRANSWARMER
• Type of Device: TRANSWARMER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct CT 06611
• MDR Report Key: 9504551
• MDR Text Key: 175188146
• Report Number: 1216677-2019-00322
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K934631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 20421
• Device Catalogue Number: 20421
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other